ClearanceBrief
Panels › Microbiology › Product code LFX · Class 2

Enzyme Linked Immunoabsorbent Assay, Rubella

Regulation 866.3510

1510(k)s in 12 months (94 all time)
0recalls in 12 months (15 all time)
12recalls that name a 510(k)
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Top companies in LFX

Company510(k)sRecalls
Abbott Laboratories83
Zeus Scientific, Inc.51
Diamedix Corp.50
Gull Laboratories, Inc.50
Labsystems, Inc.50
Ortho Diagnostic Systems, Inc.50
Bio-Rad Laboratories22
DiaSorin, Inc.31
Siemens Healthcare Diagnostics Inc.04
Bayer Corp.30
Decided510(k)Device and applicantCode
Aug 9, 1990K902925VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
Vitek Systems, Inc.
LFX
Jul 31, 1990K902793RUBELLA IGG
Pharmacia Diagnostics, Inc.
LFX
Jun 28, 1990K901635RUBELLA IGG ELISA TEST
Gull Laboratories, Inc.
LFX
Dec 29, 1989K896479ORTHO* RUBELLA-G ANTIBODY ELISA TEST
Ortho Diagnostic Systems, Inc.
LFX
Dec 21, 1989K894946PLATELIA RUBELLA IGG KIT
Kallestad Diag, A Div. of Erbamont, Inc.
LFX
Oct 16, 1989K894546IMMUNODOT RUBELLA TEST
General Biometrics, Inc.
LFX
Sep 13, 1989K892202DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
Gull Laboratories, Inc.
LFX
Aug 30, 1989K894544BIOTROL RUB-E.I.A. TEST G
Biotrol, USA, Inc.
LFX
Aug 15, 1989K885300CAPTIA(R) RUBELLA-M
Mercia Diagnostics , Ltd., GB
LFX
Aug 15, 1989K883924CAPTIA(R) RUBELLA-G
Mercia Diagnostics , Ltd., GB
LFX
Aug 3, 1989K891783RUBELLA ELISA TEST SYSTEM
Zeus Scientific, Inc.
LFX
Jun 23, 1989K885297IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
Abbott Laboratories
LFX
Jun 23, 1989K885295IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
Abbott Laboratories
LFX
Jun 8, 1989K892051RUBELLA-CUBE(TM)
Difco Laboratories, Inc.
LFX
Apr 10, 1989K884247MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT
Disease Detection International, Inc.
LFX
Feb 3, 1989K890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
Labsystems, Inc., FI
LFX
Feb 3, 1989K884898IMMUNODOT TORCH TEST RUBELLA
General Biometrics, Inc.
LFX
Feb 2, 1989K885082IMMUNODOT RUBELLA TEST
General Biometrics, Inc.
LFX
Feb 2, 1989K884617ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
Ortho Diagnostic Systems, Inc.
LFX
Jan 31, 1989K882999RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
Organon Teknika Corp.
LFX
Oct 31, 1988K883182FIAGEN RUBELLA IGG
Cyberfluor, Inc., CA
LFX
Oct 25, 1988K883778RUBELLA IGM MICROASSAY
Diamedix Corp.
LFX
Oct 6, 1988K882475AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
Amersham Corp.
LFX
Apr 4, 1988K881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201
Labsystems, Inc.
LFX
Mar 23, 1988K875368THE DDI SERODOT RUBELLA IGG TEST KIT
Disease Detection International, Inc.
LFX
Oct 15, 1987K873780MODIFICATION RUBELLA IGM EIA TEST KIT
Labsystems, Inc.
LFX
Sep 9, 1987K873088VIRGO(TM) RUBELLA IGG ELISA
Electro-Nucleonics Laboratories, Inc.
LFX
Aug 24, 1987K872071CHROMOTITRE E.I.A. RUBELLA IGG
Ismunit Istituto Immunologico Intaliano, IT
LFX
Apr 14, 1987K864602RUBELLA MICROASSAY
Diamedix Corp.
LFX
Feb 2, 1987K864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY
Cytotech, Inc.
LFX
Aug 8, 1986K862431RUBELLA IGM EIA TEST KIT
Labsystems, Inc.
LFX
Jul 14, 1986K860145RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
Clinical Sciences, Inc.
LFX
Jun 17, 1986K853696RUBELLA IGG EIA TEST KIT
Labsystems, Inc.
LFX
Jun 13, 1986K861282MUREX SUDS RUBELLA
Murex Corp.
LFX
May 1, 1986K854618CORDOT R
Cordis Corp.
LFX
Jan 1, 1986K853069TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
Hybritech, Inc.
LFX
May 21, 1984K841200RUBELLA IGG ANTIBODY ELISA TEST SYS
Ortho Diagnostic Systems, Inc.
LFX
Mar 17, 1983K822342ORTHO RUBELLA ELISA TEST SYSTEM
Ortho Diagnostic Systems, Inc.
LFX
Sep 14, 1982K821804RUBELLA RQ BIO-ENZABEAD KIT
Litton Bionetics
LFX
Mar 4, 1982K813493ENZYGNOST TM RUBELLA IGM
Calbiochem-Behring Corp.
LFX
Nov 27, 1981K812787EIA RUBELLA
Gilford
LFX
Jan 29, 1981K803175RUBELLA VIRUS SEROLOGICAL REAGENTS
Microbiological Research Corp.
LFX
Jan 29, 1981K803133RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL
Microbiological Research Corp.
LFX
Nov 16, 1979K791746ROTAZYME
Abbott Laboratories
LFX

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