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510(k) K963111

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

K963111 is an FDA 510(k) premarket notification submitted by Chromogenix AB for the device "COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S". The FDA issued a decision of Substantially Equivalent on December 23, 1996. The device falls under product code GGW (Test, Time, Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Chromogenix AB has at least 3 other 510(k) clearances on record.

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

  • K260551 — HemosIL Factor V Leiden (APC Resistance V) (March 20, 2026)
  • K090105 — LUPOTEK KCT (December 30, 2010)
  • 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)

FDA data resources