510(k) Report

510(k) · Cleared

Cleared

Merifluor-Cryptosporidium/Giardia

K912408510(k) TraditionalCleared Jul 24, 199154-day reviewClass II21 CFR 866.3220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Meridian Diagnostics, Inc. · MHI Giardia Spp.

Cleared on Jul 24, 1991 after a 54-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.

Decided
Jul 24, 1991
Review
54 days
Class
Class II
Product code
MHI
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2011: 1 descendant cleared2005: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK912408 Merifluor-Cryptosporidium/GiardiaMeridian Diagnostics, Inc. · 1991
  2. Descendant · cites it directly · 1 of its ownK051929 Giardia/Cryptosporidium ChekTechlab, Inc. · 2005
  3. Descendant · 2 generations on · 0 of its ownK171078 Tri-Combo Parasite ScreenTechlab, Inc. · 2017
  4. Descendant · cites it directly · 0 of its ownK103673 Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011
  5. Descendant · cites it directly · 0 of its ownK024113 Ivd Crypto/Giardia DfaIvd Research, Inc. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K051929Giardia/Cryptosporidium ChekTechlab, Inc. · 2005 · cites it directly1descendant
  • K171078Tri-Combo Parasite ScreenTechlab, Inc. · 2017 · 2 generations on0descendants
  • K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011 · cites it directly0descendants
  • K024113Ivd Crypto/Giardia DfaIvd Research, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912408Merifluor-Cryptosporidium/GiardiaMeridian Diagnostics, Inc.1991—
+1K051929Giardia/Cryptosporidium ChekTechlab, Inc.2005—
+2K171078Tri-Combo Parasite ScreenTechlab, Inc.2017—
+1K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center2011—
+1K024113Ivd Crypto/Giardia DfaIvd Research, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
201110
201710
FIG. 1 — Lineage of K912408, 1991–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MHI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051929Giardia/Cryptosporidium ChekTechlab, Inc.20051
K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center20110
K024113Ivd Crypto/Giardia DfaIvd Research, Inc.20030

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051929 (Techlab, Inc., 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MHI devices

MHI Giardia Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHI

1in 2013

2009: 12011: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHI

Too few MHI 510(k)s in any year since 2007 to give a median.

Recalls per year · MHI

1in 2025

2008: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHI

No MAUDE report names MHI since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—10
20091—00
20100—00
20111—00
20120—00
20131—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

More from Meridian Diagnostics, Inc.

92 FDA decisions under this applicant name. See the company

  • K993914Premier Toxins a&B, Model 616096Meridian Diagnostics, Inc. · 19992 recalls
  • K990263Immunocard Stat! E. Coli O157:H7Meridian Diagnostics, Inc. · 1999
  • K984343Premier Type Specific HSV-1 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K984346Premier Type Specific HSV-2 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19981 recall

Recent decisions in MHI

The MHI category page

  • K120001Unigold GiardiaTrinity Biotech · 2013
  • K103673Giardia/ Cryptosporidium Quik ChekTechlab Inc., Corporate Research Center · 2011
  • K081064Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LFIvd Research, Inc. · 2009
  • K031942Xpect Giardia Lateral Flow Assay, Model 2450020Remel, Inc. · 2003
  • K031834Xpect Giardia/Cryptosporidium Lateral Flow AssayRemel, Inc. · 20031 recall

https://510kreport.com/device/K912408 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912408: Merifluor-Cryptosporidium/Giardia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912408

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026