510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904496Substantially Equivalent

Cromatest Syphilis Diagnostic

Biotrax, Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904496 is the FDA 510(k) clearance record for CROMATEST SYPHILIS DIAGNOSTIC, a class II device, cleared for Biotrax, Inc. on under FDA product code GMQ (Antigens, Nontreponemal, All). FDA records list 4 510(k) clearances for Biotrax, Inc., from to . As of , FDA records show no recalls naming K904496.

Clearance record

Decision date
Received
(295 days to decision)
Product code
GMQ Antigens, Nontreponemal, All
Regulation
21 CFR 866.3820
Device class
Class II
Review panel
Microbiology
Applicant
Biotrax, Inc. 5202 Westland Blvd., Baltimore MD
Third party review
No

Clearances, product code GMQ

Trailing 12 months

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

FDA records show no clearances under product code GMQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GMQ, 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