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510(k) K050821

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM by Zycare — Product Code KQG

K050821 is an FDA 510(k) premarket notification submitted by Zycare for the device "COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 16, 2005. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2005
Date Received
March 31, 2005
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 for product code KQG

  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • 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