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510(k) K010325

Device
WAKO AUTOKIT C4
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K010325
Product code
DBI  
Decision
Substantially Equivalent (SESE)
Decision date
2001-06-25
Date received
2001-02-02
Regulation
866.5240
Classification name
Complement C4, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TONYA MALLORY
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DBI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K100455SPAPLUS ANALYZERThe Binding Site2010-09-03
K012359TINA-QUANT COMPLEMENT C4 TEST SYSTEMRoche Diagnostics Corp.2001-11-29
K000468RANDOX COMPLEMENT C4Randox Laboratories, Ltd.2000-03-27
K994293DIMENSION C4 FLEX REAGENT CARTRIDGEDade Behring, Inc.2000-03-01
K981785C4 MININEPH ANTISERUMThe Binding Site, Ltd.1999-12-20
K993481K-ASSAY C4Kamiya Biomedical Co.1999-11-29
K983356C4Abbott Laboratories1998-11-04
K964300N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.1997-07-14
K964297N-ASSAY TIA C4 TEST KITCrestat Diagnostics, Inc.1997-07-14
K962582OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.1996-10-18
K962198QUANTEX C4Instrumentation Laboratory CO1996-09-26
K920010IL TEST COMPLEMENT 4Instrumentation Laboratory CO1992-03-13
K911899RAICHEM SPIA C4 REAGENTReagents Applications, Inc.1991-05-09
K892129EZ COMPLEMENT C4Diamedix Corp.1989-04-14
K890564SPQ(TM) ANTIBODY REAGENT SET II FOR C4Atlantic Antibodies1989-02-17

Legacy Summary#

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FDA Review#

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