510(k) Report

510(k) · Cleared

Cleared

Histoplasma Capsulatum, Antigen Yeast

K792704510(k) TraditionalCleared Jan 17, 198021-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. · GMJ Antigens, Histoplasma Capsulatum, All

Cleared on Jan 17, 1980 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 17, 1980
Review
21 days
Class
Class II
Product code
GMJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K792704Source: 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.

Planning a device in GMJ? 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
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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 GMJ devices

GMJ Antigens, Histoplasma Capsulatum, All: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMJ

FDA has decided no GMJ device since 2007.

Median 510(k) review, days · GMJ

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

Recalls per year · GMJ

No recall names GMJ since 2007.

Adverse event reports per year · GMJ

No MAUDE report names GMJ 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
  • K984346Premier Type Specific HSV-2 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K984343Premier Type Specific HSV-1 Igg Elisa TestMeridian Diagnostics, Inc. · 1999
  • K983255Modification to: Premier Platinum HpsaMeridian Diagnostics, Inc. · 19981 recall

Recent decisions in GMJ

The GMJ category page

  • K830837LA-Histo Antibody System #HL 1001Immuno-Mycologics, Inc. · 19831 recall
  • K813359Myco-Immune TM Histoplasmin Latex AgglAmerican Scientific Products · 1981
  • K802130Immuno. Identification of H. CapsulatumNolan Biological Laboratories, Inc. · 1980
  • K792701Histoplasma Capsulatum, AntigenMeridian Diagnostics, Inc. · 1980
  • K792711Histoplasma Capsulatum, AntiserumMeridian Diagnostics, Inc. · 1980

https://510kreport.com/device/K792704 · printed Nov 5, 2026

Cite this page

510(k) Report. “K792704: Histoplasma Capsulatum, Antigen Yeast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K792704

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