ClearanceBrief
Panels › Microbiology › Product code GOL · Class 2

Antigen, Ha (Including Ha Control), Rubella

Regulation 866.3510

0510(k)s in 12 months (21 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in GOL

Decided510(k)Device and applicantCode
Jun 7, 1984K841174RUBELLA ANTIBODY FLUOROIMMUNOASSAY
Intl. Diagnostic Technology
GOL
Apr 17, 1984K834032RUBAQUICK DIAGNOSTIC KIT
Abbott Laboratories
GOL
Mar 11, 1981K810309RUBELLA ANTIBODIES TEST REAGENTS
Calbiochem-Behring Corp.
GOL
Dec 18, 1980K802508RUBELISA IGM TEST KIT
M.A. Bioproducts
GOL
Dec 18, 1980K802339EIA RUBELLA-G
Beckman Instruments, Inc.
GOL
Dec 18, 1980K802102RUBELLA ELISA REAGENTS RUBELLA IGG ANTI
Calbiochem-Behring Corp.
GOL
Oct 23, 1980K801667GAMMA COAT(125 I) RUBELLA ANTIBODY
Clinical Assays, Inc.
GOL
Sep 16, 1980K801098ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES)
Flow Laboratories, Inc.
GOL
Aug 20, 1980K801507ANTIGEN CONTROL CELLS
Ortho Diagnostics, Inc.
GOL
Jun 30, 1980K800789RUBELLA BIO-BEAD TITRATION KIT
Litton Bionetics
GOL
Jun 20, 1980K800797MACRO-VUE RUBELLA CARD TEST
Bd Becton Dickinson Vacutainer Systems Preanalytic
GOL
Jan 23, 1980K792249FIAX TEST KIT FOR ANTI-RUBELLA ANTIBOD
Intl. Diagnostic Technology
GOL
Nov 13, 1979K791610RUBELLA BIO-BEAD SCREEN KIT
Litton Bionetics
GOL
Aug 16, 1979K790976RUBAZYME
Abbott Laboratories
GOL
Apr 12, 1979K790212CORDIA T
Cordis Corp.
GOL
Jan 17, 1979K780885CORDIA R
Cordis Corp.
GOL
Oct 18, 1977K771796RUBA-NOST TEST KITS
Behring Diagnostics, Inc.
GOL
May 20, 1977K770809MEASLES-FA LABELED PRESERUM (8-441 RNF)
Flow Laboratories, Inc.
GOL
May 20, 1977K770805MEASLES-FA LABELLED (8-441 RF)
Flow Laboratories, Inc.
GOL
Mar 1, 1977K770092HERPESIVIRUS TEST (TYPE L & 2)
Microbiological Research Corp.
GOL
Nov 16, 1976K760889TEST FOR DETECTION OF ANTIRUBELLA ANTIB
Abbott Laboratories
GOL

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