510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920401Substantially Equivalent

Immunowell Cardiolipin Antibody (Igm) Test

General Biometrics, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920401 is the FDA 510(k) clearance record for IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST, a class II device, cleared for General Biometrics, Inc. on under FDA product code MID (System, Test, Anticardiolipin Immunological). FDA records list 23 510(k) clearances for General Biometrics, Inc., from to . As of , FDA records show no recalls naming K920401.

Clearance record

Decision date
Received
(204 days to decision)
Product code
MID System, Test, Anticardiolipin Immunological
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
General Biometrics, Inc. 15222 Ave. Of Science, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code MID

Trailing 12 months

FDA records hold no clearances under product code MID in the trailing twelve months.

FDA records show no clearances under product code MID in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MID, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260