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GGC — Control, Plasma, Abnormal Class II

FDA Device Classification

Classification Details

Product Code
GGC
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
K102552instrumentation laboratoryHEMOSIL LA POSITIVE CONTROLApril 5, 2011
K100103helena laboratoriesSPECIALTY ASSAYED CONTROL-2December 15, 2010
K062306r2 diagnosticsPLASMACON N, PLASMACON L-1, PLASMACON L-2March 16, 2007
K061803diagnostica stagoSTA - CONTROL LA 1+2July 28, 2006
K032804precision biologicCRYOCHECK WEAK LUPUS POSITIVE CONTROLNovember 3, 2003
K023312dade behringCONTROL PLASMA PNovember 1, 2002
K020878bio-radLYPHOCHEK HEMOSTASIS, MODELS 798, 799April 15, 2002
K020109sigma diagnosticsSIGMA DIAGNOSTICS ACCUCLOT LA CONTROLFebruary 6, 2002
K012422kamiya biomedicalK-ASSAY D-DIMER CONTROLSAugust 21, 2001
K003329sigma diagnosticsSIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217March 1, 2001
K993332gradiporeGRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05February 16, 2000
K984131pacific hemostasisCOAGULATION CONTROL LEVEL 3 (ABNORMAL)December 1, 1998
K984130pacific hemostasisCOAGULATION CONTROL LEVEL 2 (ABNORMAL)December 1, 1998
K961370medical diagnostic technologiesLA POSITIVE CONTROL PLASMAMay 24, 1996
K955040american bioproductsAT-III CONTROL PLASMA KITJanuary 31, 1996
K952623precision biologicalsCRYO CHECK LUPUS PLASMANovember 6, 1995
K952624precision biologicalsCRYO CHECK ABNORMAL REFERENCE CHECK I & IIOctober 30, 1995
K945856george king bio-medicalPOSITIVE LUPUS ANTICOAGULANT PLASMAOctober 5, 1995
K952338american bioproductsSTA-COAG CONTROL [P] PLUS KITSeptember 21, 1995
K941872helena laboratoriesSPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302November 21, 1994