510(k) Report

510(k) · Cleared

Cleared

Permier Histoplasma

K915700510(k) TraditionalCleared Jul 30, 1992220-day reviewClass II21 CFR 866.3320

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

Meridian Diagnostics, Inc. · MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum

Cleared on Jul 30, 1992 after a 220-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 30, 1992
Review
220 days
Class
Class II
Product code
MIZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K915700Source: FDA 510(k) database · How lineage is built

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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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All MIZ devices

MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MIZ

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MIZ

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

Recalls per year · MIZ

No recall names MIZ since 2007.

Adverse event reports per year · MIZ

No MAUDE report names MIZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
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 MIZ

The MIZ category page

  • K101407Alpha Histoplasma Antigen Eia Model HAG102Immuno-Mycologics, Inc. · 2011

https://510kreport.com/device/K915700 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915700: Permier Histoplasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915700

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