Home / 510(k) Clearances / K894467

510(k) K894467

THROMBIN TIME REAGENT by Sigma Chemical Co. — Product Code GJA

K894467 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "THROMBIN TIME REAGENT". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code GJA (Test, Thrombin Time), a Class II device regulated under 21 CFR 864.7875. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1989
Date Received
July 18, 1989
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

Other clearances by Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

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)
  • K884384 — THROMBIN-PREST REAGENT KIT (December 28, 1988)
  • K884385 — FIBRI-PREST/THROMBIN-PREST CONTROLS (December 28, 1988)

FDA data resources