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510(k) K942049

BIOMERIEUX HEMOLAB COFAC II by Biomerieux Vitek, Inc. — Product Code GJT

K942049 is an FDA 510(k) premarket notification submitted by Biomerieux Vitek, Inc. for the device "BIOMERIEUX HEMOLAB COFAC II". The FDA issued a decision of Substantially Equivalent on May 19, 1995. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Biomerieux Vitek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1995
Date Received
April 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by Biomerieux Vitek, Inc.

  • K973819 — VIDAS D-DIMER (DD) ASSAY (March 10, 1998)
  • K972895 — VIDAS ROTAVIRUS (RTV) ASSAY (October 3, 1997)
  • K965092 — VIDAS ROTAVIRUS ASSAY (May 5, 1997)
  • K964887 — VIDAS C. DIFFICILE TOXIN A II ASSAY (April 8, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K962609 — GRAM NEGATIVE IDENTIFICATION PLUS CARD (August 30, 1996)
  • K962549 — VIDAS CREATINE KINASE MB ASSAY 30-421 (August 30, 1996)
  • K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) (March 12, 1996)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K943812 — VIDAS LYME SCREEN II (June 13, 1995)

Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K180486 — HemosIL Factor XII Deficient Plasma (March 22, 2018)
  • K102908 — NOFACT IX (December 19, 2011)
  • K102851 — NOFACT VIII (December 19, 2011)
  • K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (July 8, 2011)
  • K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA (May 2, 2005)
  • K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA (February 9, 2005)
  • K040362 — DIAPHARMA FACTOR X KIT (July 12, 2004)
  • K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (February 13, 2004)
  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (July 31, 2003)

FDA data resources