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CZW — Complement C3, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
CZW
Device Class
Class II
Regulation Number
866.5240
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100179binding site groupSPAPLUSAugust 13, 2010
K063150thermo electronCOMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLMarch 19, 2007
K061852dade behringDIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL September 22, 2006
K050665dade behringN ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)May 2, 2005
K042494ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMAOctober 19, 2004
K032796iblIBL C3D-CIC EIA TESTJanuary 13, 2004
K032035beckman coulterSYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT CAugust 7, 2003
K012361roche diagnosticsTINA-QUANT COMPLEMENT C3C TEST SYSTEMNovember 29, 2001
K010326wako chemicals usaWAKO AUTOKIT C3June 25, 2001
K000469randox laboratoriesRANDOX COMPLEMENT C3March 27, 2000
K994296dade behringDIMENSION C3 FLEX REAGENT CARTRIDGEMarch 1, 2000
K981783binding siteC3 MININEPH ANTISERUMDecember 20, 1999
K993437kamiya biomedicalK-ASSAY C3November 24, 1999
K991907bayerADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMNovember 9, 1999
K983441abbott laboratoriesC3November 4, 1998
K964298crestat diagnosticsN-ASSAY TIA MULTI V-NLJuly 14, 1997
K964842beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENTJune 11, 1997
K962409olympus americaOLYMPUS C3 IMMUNOTURBIDIMETRIC REGENTOctober 18, 1996
K962199instrumentation laboratoryQUANTEX C3September 25, 1996
K955857behring diagnosticsN PROTEIN STANDARS SYFebruary 21, 1996