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

Company510(k)sRecalls
Diagnostic Products Corp.50
Amersham Corp.40
Leeco Diagnostics, Inc.40
Monoclonal Antibodies, Inc.40
Nichols Institute Diagnostics40
Pcl-Ria, Inc.40
Unipath , Ltd.40
Armkel, LLC30
Bio-Rad30
Ciba Corning Diagnostics Corp.30
Decided510(k)Device and applicantCode
Mar 17, 1986K860308SUCROSEP LUTEINIZING HORMONE (LH) IRMA
Boots-Celltech Diagnostics, Inc., GB
CEP
Feb 28, 1986K855173DELFIA TM HLH KIT
Lkb Instruments, Inc.
CEP
Jan 7, 1986K854838LEE-BEAD BETA LH (EIA)
Leeco Diagnostics, Inc.
CEP
Dec 17, 1985K853142OVUTIME OVULATION PREDICTOR TEST
Advanced Care Products
CEP
Oct 16, 1985K853837LH/FSH RADIOIMMUNOASSAY KIT
Bioclinical Group
CEP
Jul 29, 1985K852146QUIDEL QUEST OVULATION TEST
Quidel Corp.
CEP
Jul 29, 1985K851445COLOR OVULATION TEST
Nms Pharmaceuticals, Inc.
CEP
Jul 9, 1985K852376SIMULTANEOUS LH/FSH SYSTEM BY RIA
American Bioclinical, Inc.
CEP
Jul 9, 1985K851332BLHI LUTEINIZING HORMONE
Euro-Diagnostics BV
CEP
Apr 10, 1985K851104AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
Amersham Corp.
CEP
Mar 5, 1985K850480OVU STICK SELF-TEST -MODIFICATION
Monoclonal Antibodies, Inc.
CEP
Dec 11, 1984K843284OVUSTICK SELF-TEST
Monoclonal Antibodies, Inc.
CEP
Nov 27, 1984K841545ENZYME IMMUNOASSAY FOR DETECTION HORM
Btc Diagnostics, Inc.
CEP
Sep 4, 1984K842445LH RIA
Syncor Intl. Corp.
CEP
Apr 13, 1984K840412OVU STICK URINE HLH KIT
Monoclonal Antibodies, Inc.
CEP
Mar 23, 1984K840188MICROMEDIC LH & FSH RIA KIT
Micromedic Systems
CEP
Mar 19, 1984K840174LH QUIK RIA KIT
Pacific Biotech, Inc.
CEP
Jan 13, 1984K833854LH RIA
Syncor Intl. Corp.
CEP
Dec 20, 1983K833376RIANEN LUTEINIZING HORMONE RIA KIT
New England Nuclear
CEP
Dec 28, 1982K823476GAMMADAB LH RADIO-KIT #CA-1508
Clinical Assays, Inc.
CEP
Dec 22, 1982K823380125-I LH RADIOIMMUNOASSAY KIT
Clinetics Corp.
CEP
Sep 13, 1982K822288LH (125I) RADIOIMMUNOASSAY
Corning Medical & Scientific
CEP
May 28, 1982K821346QUANTIMUNE HLH RIA
Bio-Rad
CEP
Apr 16, 1982K820760LH RADIOIMMUNOASSAY TEST SYSTEM
Monobind
CEP
Apr 14, 1982K820741MR1 LUTROPIN RIA KIT
Microanalytic Research, Inc.
CEP
Apr 9, 1982K820753AMERLEX LH RIA KIT (CODE IM2081)
Amersham Corp.
CEP
Mar 25, 1982K820357LUTEINIZING HORMONE KIT
Pcl-Ria, Inc.
CEP
Dec 22, 1981K813213SHARIA-LH RIA KIT FOR QUANTITATION HORMO
Intl. Immunoassay Laboratories, Inc.
CEP
Jul 27, 1981K811994RADIOIMMUNOASSAY LUTEINIZING HORMONE
Endocrine-Metabolic Center
CEP
May 8, 1981K811024LUTEINIZING HORMONE DIRECT RIA KIT 125/I
Immunalysis Corporation
CEP
Mar 31, 1981K810754LUTENIZING HORMONES
Pcl-Ria, Inc.
CEP
Mar 31, 1981K810741LUTEINIZING HORMONE
Pcl-Ria, Inc.
CEP
Mar 31, 1981K810662LEECO LH-QUANT DIAGNOSTIC KIT
Leeco Diagnostics, Inc.
CEP
Feb 25, 1981K810302QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
Bio-Rad
CEP
Jan 21, 1981K803278LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
Immuno Nuclear Corp.
CEP
Feb 13, 1980K800106LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS
Radioimmunoassay, Inc.
CEP
Jan 16, 1980K792350CENTRIA LH RIA
Union Carbide Corp.
CEP
Oct 30, 1979K792000LUTEINIZING HORMONE (LH) RIA
Cis Radiopharmaceuticals, Inc.
CEP
Sep 17, 1979K791405125I LEUTINIZING HORMONE RIA KIT
Diagnostic Products Corp.
CEP
Oct 27, 1978K781685RIA KIT, LH
Amersham Corp.
CEP
May 19, 1978K780576125-I LABELED HUMAN LUTEINIZING HORMONE
Pcl-Ria, Inc.
CEP
Apr 28, 1978K780367RIA SYS. FOR HUMAN LUTEINIZING HORMONE
Calbiochem-Behring Corp.
CEP
May 26, 1977K770854LUTEINIZING HORMONE RIA REAGENT, LH-RIA
Nichols Institute Diagnostics
CEP

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