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510(k) K904416

CROATEST (R) RHEUMATOID DIAGNOSTIC by Biotrax, Inc. — Product Code GTQ

K904416 is an FDA 510(k) premarket notification submitted by Biotrax, Inc. for the device "CROATEST (R) RHEUMATOID DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on June 24, 1991. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Biotrax, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
September 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

Other clearances by Biotrax, Inc.

  • K904496 — CROMATEST SYPHILIS DIAGNOSTIC (July 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 GTQ

  • K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD (December 14, 2005)
  • K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (October 20, 1995)
  • K915742 — TURBIQUANT ASL (June 28, 1993)
  • K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT (June 15, 1993)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)
  • K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (March 19, 1992)
  • K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (July 17, 1991)
  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)

FDA data resources