510(k) Report

510(k) · Cleared

Cleared

Aspergillus Fumigatus, Aspergillus Flavu

K790672510(k) TraditionalCleared May 31, 197955-day reviewClass I21 CFR 866.3040

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

Diagnostica, Inc. · JWT Antigen, Cf, Aspergillus Spp.

Cleared on May 31, 1979 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 31, 1979
Review
55 days
Class
Class I
Product code
JWT
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790672Source: 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 JWT devices

JWT Antigen, Cf, Aspergillus Spp.: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWT

FDA has decided no JWT device since 2007.

Median 510(k) review, days · JWT

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

Recalls per year · JWT

No recall names JWT since 2007.

Adverse event reports per year · JWT

No MAUDE report names JWT 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 Diagnostica, Inc.

12 FDA decisions under this applicant name. See the company

  • K002756Ease-a-CultDiagnostica, Inc. · 2001
  • K823348H. Influenza B Antisera for CieDiagnostica, Inc. · 1982
  • K812434Diagnostic Kits & Kit ComponentsDiagnostica, Inc. · 1981
  • K800398Paracontrol Abnormal Immunoglobulin ContDiagnostica, Inc. · 1980
  • K791283Anti-Human Lambda SerumDiagnostica, Inc. · 1979

Recent decisions in JWT

The JWT category page

  • K812740Reagents for Serodiagnosis of AspergillNolan Biological Laboratories, Inc. · 1981
  • K792700Aspergillus SP, Complement FixationMeridian Diagnostics, Inc. · 1980
  • K791387Aspergillus Mycelial Antigen #CF10024XImmuno-Mycologics, Inc. · 1979
  • K760830Aspergillus Mycelial AntigenI M, Inc. · 1976

https://510kreport.com/device/K790672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790672: Aspergillus Fumigatus, Aspergillus Flavu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790672

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