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510(k) K993480

Device
K-ASSAY HAPTOGLOBIN
Applicant
KAMIYA BIOMEDICAL CO.
510(k) number
K993480
Product code
DAD  
Decision
Substantially Equivalent (SESE)
Decision date
1999-11-24
Date received
1999-10-14
Regulation
866.5460
Classification name
Haptoglobin, Antigen, Antiserum, Control
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
COLIN GETTY
Address
910 Industry Dr. Seattle WA US 98188 98188

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DAD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972639TINA-QUANT HAPTOGLOBINBoehringer Mannheim Corp.1998-01-09
K964301N-ASSAY TIA MULTI V-NLCrestat Diagnostics, Inc.1997-07-14
K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTBeckman Instruments, Inc.1996-10-07
K952593N/T PROTEIN CONTROL SY/L, M AND HBehring Diagnostics, Inc.1995-07-17
K915829IL TEST(TM) HAPTOGLOBIN (HPT)Instrumentation Laboratory CO1992-07-29
K911898RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENTReagents Applications, Inc.1991-05-08
K890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTAtlantic Antibodies1989-02-22
K873866HAPTOGLOBINUnipath , Ltd.1987-10-20
K872717QM300 HAPTOGLOBIN ANTIBODY PACKKallestad Diag, A Div. of Erbamont, Inc.1987-07-21
K864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOCooper Biomedical, Inc.1987-02-13
K850584SPQ TEST SYSTEM FOR HAPTOGLOBINApplications Lab1985-03-05
K840404DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNOTago, Inc.1984-03-09
K831957DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOBKent Laboratories, Inc.1983-07-18
K812494IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTODako Corp.1981-09-23
K801433HAPTOGLOBIN NEPHELOMETRIC ASSAYJ.T. Baker Chemical Co.1980-07-08

Legacy Summary#

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FDA Review#

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