510(k) Report

510(k) · Cleared

Cleared

Coccidiodes (Cocci)

K791381510(k) TraditionalCleared Aug 16, 197936-day reviewClass II21 CFR 866.3135

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

Immuno-Mycologics, Inc. · GMG Antigen, Latex Agglutination, Coccidioides Immitis

Cleared on Aug 16, 1979 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 16, 1979
Review
36 days
Class
Class II
Product code
GMG
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K791381Source: FDA 510(k) database · 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 GMG? 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 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 GMG devices

GMG Antigen, Latex Agglutination, Coccidioides Immitis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMG

FDA has decided no GMG device since 2007.

Median 510(k) review, days · GMG

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

Recalls per year · GMG

No recall names GMG since 2007.

Adverse event reports per year · GMG

No MAUDE report names GMG 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 Immuno-Mycologics, Inc.

26 FDA decisions under this applicant name. See the company

  • K120946Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc. · 2012
  • K112422Crag Lateral Flow Assay (Lfa)Immuno-Mycologics, Inc. · 20123 recalls
  • K102286Crag Lateral Flow Assay (Crag Lfa)Immuno-Mycologics, Inc. · 2011
  • K101407Alpha Histoplasma Antigen Eia Model HAG102Immuno-Mycologics, Inc. · 2011
  • K883333Rabbit Plasma Fibrinogen (RPF) SupplementImmuno-Mycologics, Inc. · 1988

Recent decisions in GMG

The GMG category page

  • K812189Coccidioides Latex AgglutinationAmerican Scientific Products · 1981
  • K792690Coccidioides Immitis, Latex AgglutiMeridian Diagnostics, Inc. · 1980
  • K782070Reagent, Cocci LatexI M, Inc. · 1979
  • K760829Coccidioides Mycelial AntigenI M, Inc. · 1976

https://510kreport.com/device/K791381 · printed Nov 4, 2026

Cite this page

510(k) Report. “K791381: Coccidiodes (Cocci).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K791381

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
  • Page last updated Nov 3, 2026