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510(k) K963111

COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S by Chromogenix AB — Product Code GGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
August 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

Other clearances by Chromogenix AB

  • K952515 — COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY (January 23, 1996)
  • K952514 — COACUTE HEPARIN (November 20, 1995)
  • K922201 — COAMATE PROTEIN C CHROMOGENIC ASSAY (December 7, 1992)

Other clearances for product code GGW

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  • K083729 — HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHE (May 8, 2009)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K042762 — PEFAKIT APC-R FACTOR V LEIDEN (December 22, 2004)
  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)
  • K992456 — GRADILEIDEN V TEST (December 21, 1999)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K945940 — COATEST(R) APC(TM) RESISTANCE (August 7, 1995)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)
  • K924370 — STACLOT(R) PNP TEST KIT (August 9, 1993)