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510(k) K845000

THROMBINEX BOVINE THROMBIN by Bio/Data Corp. — Product Code GJA

K845000 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "THROMBINEX BOVINE THROMBIN". The FDA issued a decision of Substantially Equivalent on March 26, 1985. The device falls under product code GJA (Test, Thrombin Time), a Class II device regulated under 21 CFR 864.7875. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1985
Date Received
December 26, 1984
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 Bio/Data Corp.

  • K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C (July 12, 2000)
  • K943153 — MICROSAMPLE COAGULATION ANALYZER (March 24, 1995)
  • K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C (June 23, 1989)
  • K881150 — KINETIC FIBRINOGEN ASSAY (March 28, 1988)
  • K873382 — PLATELET EXTRACT REAGENT (November 20, 1987)
  • K860751 — VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA (March 18, 1986)
  • K860342 — MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP (March 4, 1986)
  • K854546 — MICROSAMPLE COAGULATION ANALYSER MODEL 110P (January 7, 1986)
  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)

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)

FDA data resources