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510(k) K800926

THROMBOQUIK THROMBIN REAGENT PROD. #3551 by General Diagnostics — Product Code GJA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Thrombin Time
Device Class
Class II
Regulation Number
864.7875
Review Panel
HE
Submission Type

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  • K863877 — BENZODIAZEPINE ENZYME IMMUNOASSAY KIT (March 12, 1987)
  • K842307 — GENERAL DIAG. CEFONICID 30MCG ANTIMIC (July 20, 1984)
  • K841465 — GENERAL DIAGNOSTICS PLATELET ANTIBODY (July 2, 1984)
  • K833709 — CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK (December 30, 1983)
  • K832653 — CEFUROXIME 30MCG. SUSCEP DISK (October 14, 1983)
  • K831179 — CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP (May 9, 1983)

Other clearances for product code GJA

  • K050817 — T-TEK (December 12, 2005)
  • K982209 — ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 (October 15, 1998)
  • K970645 — BC THROMBIN REAGENT (May 19, 1997)
  • K925493 — BIOMERIEUX HEMOLAB THROMBICALCI-TEST (April 21, 1994)
  • K930157 — TEST THROMBIN (May 14, 1993)
  • K923220 — THROMBIN CLOT TIME TEST PROCEDURE (September 29, 1992)
  • K920147 — THROMBIN CLOTTING TIME REAGENT (May 1, 1992)
  • K900126 — TT AND HNTT BY HEMOCHRON (February 5, 1990)
  • K894467 — THROMBIN TIME REAGENT (September 5, 1989)
  • K884384 — THROMBIN-PREST REAGENT KIT (December 28, 1988)