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GIZ — Plasma, Control, Normal Class II

FDA Device Classification

Classification Details

Product Code
GIZ
Device Class
Class II
Regulation Number
864.5425
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060968wortham laboratoriesSTASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M;May 15, 2007
K042941dade behringDADE BEHRING HEPARIN CALIBRATOR AND CONTROLSDecember 2, 2004
K023309dade behringCONTROL PLASMA NNovember 1, 2002
K013708precision biologicREFERENCE CHECK, CATALOG NUMBER-RCN-10December 10, 2001
K003328sigma diagnosticsACCUCLOT CONTROL I, MODEL A4089March 1, 2001
K001256dade behringCONTROL PLASMA NMay 24, 2000
K984129pacific hemostasisCOAGULATION CONTROL LEVEL 1 (NORMAL)December 1, 1998
K973274sigma diagnosticsACCUCOLOR HIGH CALIBRATOR (A3089)October 31, 1997
K961814cardiovascular diagnosticsTHROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLSAugust 13, 1996
K941737helena laboratoriesSPECIALTY ASSAYED CONTROL-1October 7, 1994
K935254american diagnosticaDVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMASeptember 19, 1994
K924403behring diagnosticsCONTROL PLASMA NFebruary 22, 1994
K932145american diagnosticCOAGULATION REFERENCE PLASMA, NORMALOctober 18, 1993
K922021american bioproductsUNICALIBRATOR KITJune 9, 1992
K905203medical diagnostic technologiesCOAGULATION REFERENCE PLASMA, NORMALDecember 28, 1990
K895262medical diagnostic technologiesNORMAL COAGULATION CONTROL PLASMA (NCCP)October 6, 1989
K893783analytical control systemsACS ANIMAL PLASMA COAGULATION CONTROL LEVEL IJune 23, 1989
K893784analytical control systemsACS HUMAN PLASMA COAGULATION CONTROL LEVEL IJune 23, 1989
K891179elite diagnosticEDL NORMAL COAGULATION CONTROLApril 10, 1989
K880712creative laboratory productsCLP NORMAL COAGULATION CONTROLMay 6, 1988