ClearanceBrief
Panels › Clinical Chemistry › Product code CEP · Class 1

Radioimmunoassay, Luteinizing Hormone

Regulation 862.1485

0510(k)s in 12 months (143 all time)
0recalls in 12 months (6 all time)
3recalls that name a 510(k)
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Top companies in CEP

Decided510(k)Device and applicantCode
Oct 12, 1990K902786MILENIA (TM) LH
Diagnostic Products Corp.
CEP
Aug 29, 1990K903052IMMUNOCORP LH IRMA COATED TUBE
Immunocorp Sciences, Inc., CA
CEP
Aug 2, 1990K902443LUMATAG(TM) LH DIAGNOSTIC KIT
London Diagnostics, Inc.
CEP
Jul 17, 1990K902208MODIFIED OVUGEN
Biogenex Laboratories
CEP
Jun 28, 1990K902398CIBA CORNING MAGIC LITE LH IMMUNOASSAY
Ciba Corning Diagnostics Corp.
CEP
Apr 3, 1990K900779ENZYMUN TEST(R) LH
Boehringer Mannheim Corp.
CEP
Mar 1, 1990K900621FIAGEN(TM) HLH.S
Cyberfluor, Inc., CA
CEP
Feb 13, 1990K896866LUTEINIZING HORMONE-EIA-XT
In Vitro Diagnostics, Inc.
CEP
Jan 30, 1990K896642MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
Medix Biotech, Inc.
CEP
Oct 31, 1989K895094TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
Hybritech, Inc.
CEP
Oct 12, 1989K894579CLEARPLAN EASY
Unipath , Ltd., GB
CEP
Aug 15, 1989K894279LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
Bd Becton Dickinson Vacutainer Systems Preanalytic
CEP
Jul 20, 1989K891762MINICLINIC OVULATION PREDICTION TEST
Vanguard Biomedical Corp.
CEP
Jun 20, 1989K893605SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
Serono-Baker Diagnostics, Inc.
CEP
Mar 24, 1989K890510ABBOTT OVULATION PREDICTOR TEST
Abbott Laboratories
CEP
Mar 8, 1989K883814DELFIA HLH SPEC KIT
Pharmacia, Inc.
CEP
Dec 22, 1988K884498COTUBE LH IRMA ASSAY
Bio-Rad
CEP
Dec 19, 1988K883530FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
Tambrands, Inc.
CEP
Nov 29, 1988K884138ABBOTT IMX LH
Abbott Laboratories
CEP
Aug 8, 1988K882340LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
Serono Diagnostics, Inc.
CEP
Aug 4, 1988K882252PHASE II LH KIT
Vitek Systems, Inc.
CEP
Jul 28, 1988K880933AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
Amersham Corp.
CEP
Apr 18, 1988K881124ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
Nichols Institute Diagnostics
CEP
Apr 18, 1988K880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
Boots-Celltech Diagnostics, Inc., GB
CEP
Jan 11, 1988K874624FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
Cyberfluor, Inc., CA
CEP
Dec 30, 1987K874032IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
Diagnostic Products Corp.
CEP
Nov 25, 1987K870584O.P.T.(TM) OVULATION PREDICTION TEST
Warner-Lambert Co.
CEP
Nov 23, 1987K873534OVUGEN SURETEST
Biogenex Laboratories
CEP
Oct 7, 1987K873668MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
Medix Biotech, Inc.
CEP
Oct 2, 1987K871241ANSWER OVULATION TEST KIT
Armkel, LLC
CEP
Sep 29, 1987K873186LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
Serono Diagnostics, Inc.
CEP
Sep 14, 1987K873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
CEP
Aug 25, 1987K872131TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
Hybritech, Inc.
CEP
Aug 5, 1987K872727LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
Serono Diagnostics, Inc.
CEP
Aug 5, 1987K871332CLEARPLAN
Unipath , Ltd., GB
CEP
Jul 27, 1987K871726OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
Monoclonal Antibodies, Inc.
CEP
Jun 11, 1987K871602MICROCHECK LH OVULATION TEST
Syntron Bioresearch, Inc.
CEP
Feb 6, 1987K863934DPC COAT-A-COUNT IRMA LH KIT
Diagnostic Products Corp.
CEP
Feb 4, 1987K863442UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
United Biotech, Inc.
CEP
Jan 6, 1987K862055CANWEST OVU-BLUE
Canwest Medictex, Inc., CA
CEP
Nov 24, 1986K864144LUTEINIZING HORMONE (LH-IRMA) RIA KIT
Immuchem Corp.
CEP
Nov 13, 1986K863929TERUMO SENSIBEAD(TM) EIA HLH KIT
Terumo Medical Corp.
CEP
Oct 16, 1986K863679ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
Nichols Institute Diagnostics
CEP
Sep 16, 1986K861354RIGHT-DAY OVULATION HOME TEST
Leeco Diagnostics, Inc.
CEP
Aug 4, 1986K860828FORETEL, COLOR OVULATION TEST
Nms Pharmaceuticals, Inc.
CEP
Jul 29, 1986K860538RIGHT-DAY URINARY LH (EIA)
Leeco Diagnostics, Inc.
CEP
Jul 7, 1986K862180MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
Clinetics Corp.
CEP
Apr 29, 1986K860984TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
Hybritech, Inc.
CEP
Apr 21, 1986K860334VISI-CHECK HLH TEST MONOCLONAL
Bioclinical Systems, Inc.
CEP
Apr 21, 1986K860333MICRO-ELISA HLH TEST KIT MONOCLONAL
Bioclinical Systems, Inc.
CEP

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