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510(k) K904496

CROMATEST SYPHILIS DIAGNOSTIC by Biotrax, Inc. — Product Code GMQ

K904496 is an FDA 510(k) premarket notification submitted by Biotrax, Inc. for the device "CROMATEST SYPHILIS DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on July 24, 1991. The device falls under product code GMQ (Antigens, Nontreponemal, All), a Class II device regulated under 21 CFR 866.3820. Biotrax, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1991
Date Received
October 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

Other clearances by Biotrax, Inc.

  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K904497 — CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST (November 1, 1990)
  • K904498 — CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST (October 29, 1990)

Other clearances for product code GMQ

  • K250249 — Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test (October 10, 2025)
  • K201438 — ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Ev (October 21, 2020)
  • K182391 — ASI Automated ASI RPR Test for Syphilis on the ASI Evolution (November 30, 2018)
  • K173376 — ASI Evolution (June 14, 2018)
  • K150358 — Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test Syste (November 12, 2015)
  • K000687 — THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST (June 12, 2000)
  • K993633 — SYNTHETIC VDRL ANTIGEN (February 23, 2000)
  • K992124 — AVANTI POLAR LIPIDS VDRL ANTIGEN SLIDE TEST KIT WITH 10 X 0.5 ML AMPULES, AVANTI (September 20, 1999)
  • K954994 — TRUST (October 18, 1996)
  • K955136 — RPR CARD TEST KIT (July 29, 1996)

FDA data resources