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510(k) K902382

Device
C3C AND C4 RID KITS
Applicant
THE BINDING SITE, LTD.
510(k) number
K902382
Product code
CZW  
Decision
Substantially Equivalent (SESE)
Decision date
1990-09-07
Date received
1990-05-30
Regulation
866.5240
Classification name
Complement C3, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAY H GELLER
Address
Westside Towers, Suite 1000 11845 W. Olympic Blvd. Los Angeles CA US 90064 90064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CZW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100179SPAPLUSThe Binding Site Group , Ltd.2010-08-13
K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OY2007-03-19
K061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.2006-09-22
K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.2005-05-02
K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical Diagnostics2004-10-19
K032796IBL C3D-CIC EIA TESTIbl GmbH2004-01-13
K032035SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALIBeckman Coulter, Inc.2003-08-07
K012361TINA-QUANT COMPLEMENT C3C TEST SYSTEMRoche Diagnostics Corp.2001-11-29
K010326WAKO AUTOKIT C3Wako Chemicals USA, Inc.2001-06-25
K000469RANDOX COMPLEMENT C3Randox Laboratories, Ltd.2000-03-27
K994296DIMENSION C3 FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-03-01
K981783C3 MININEPH ANTISERUMThe Binding Site, Ltd.1999-12-20
K993437K-ASSAY C3Kamiya Biomedical Co.1999-11-24
K991907ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.1999-11-09
K983441C3Abbott Laboratories1998-11-04

Legacy Summary#

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FDA Review#

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