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KQG — Instrument, Coagulation Class II

FDA Device Classification

Classification Details

Product Code
KQG
Device Class
Class II
Regulation Number
864.5400
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K050821zycareCOAGCARE ANTICOAGULATION MANAGEMENT SYSTEMAugust 16, 2005
K021976vital scientific n.vFIBRON-1, FIBRON-4, QUIKCOAG, FIBRONOctober 25, 2002
K992130pacific hemostasisPACIFIC HEMOSTASIS THROMBOSCREEN 400CSeptember 3, 1999
K991321pacific hemostasisPACIFIC HEMOSTASIS THROMBOSCREEN 200June 21, 1999
K983475international technidyneHEMOCHRON RESPONSEMay 3, 1999
K902614logos scientificELVI 828 DIGICLOT MULTISCANNovember 8, 1990
K900685texas intl. laboratoriesCLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERApril 16, 1990
K862047med usaCOAGULATOR (8 CHANNEL)September 29, 1986
K852492med usaCOAGULATORAugust 13, 1985
K851169medical laboratory automation systemsELECTRA 800 AUTOMATIC COAGULATION TIMERJune 24, 1985
K823131ortho diagnostic systemsKOAGULAB 40-A AUTOMATED COAGULATION SYSDecember 9, 1982
K812906volu sol medical industriesELVI BICLOT 816July 22, 1982
K791587volu sol medical industriesELVI 810 CLOTSCANNERSeptember 17, 1979
K770914thermolyneINCUBATOR, PORTABLE, ACT-STATAugust 4, 1977