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510(k) K021976

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON by Vital Scientific N.V. — Product Code KQG

K021976 is an FDA 510(k) premarket notification submitted by Vital Scientific N.V. for the device "FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON". The FDA issued a decision of Substantially Equivalent on October 25, 2002. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Vital Scientific N.V. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
June 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Vital Scientific N.V.

  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
  • K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG CO (July 23, 2002)
  • K020840 — VITAL SCIENTIFIC PT WITH CALCIUM (May 15, 2002)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)

Other clearances for product code KQG

  • K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (August 16, 2005)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K851169 — ELECTRA 800 AUTOMATIC COAGULATION TIMER (June 24, 1985)
  • K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS (December 9, 1982)

FDA data resources