510(k) Report

510(k) · Cleared

Cleared

Premier Blastomyces

K923859510(k) TraditionalCleared Oct 5, 199266-day reviewClass II21 CFR 866.3060

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

Meridian Diagnostics, Inc. · MJL Eia, Blastomyces Dermatitidis

Cleared on Oct 5, 1992 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 5, 1992
Review
66 days
Class
Class II
Product code
MJL
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K923859Source: 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 has not posted a summary or statement for it, 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 MJL devices

MJL Eia, Blastomyces Dermatitidis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJL

FDA has decided no MJL device since 2007.

Median 510(k) review, days · MJL

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

Recalls per year · MJL

No recall names MJL since 2007.

Adverse event reports per year · MJL

No MAUDE report names MJL 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
20110—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 MJL

The MJL category page

  • K840201Epidural Catheter TrayAries Medical, Inc. · 1984

https://510kreport.com/device/K923859 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923859: Premier Blastomyces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923859

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