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
DateFirm and productCodeLinked 510(k)
Jan 4, 2023Biomerieux Inc
VIDAS CLINICAL VIDAS LH 60 TESTS, CATALOG 30406-01
Open, Classified		 CEPK921176
Mar 25, 2022Ortho-Clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Open, Classified		 CEPK964982
Sep 22, 2021bioMerieux, Inc.
VIDAS LH, REF 30406-01
Open, Classified		 CEPNone listed
Mar 5, 2018Tosoh Bioscience Inc
ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
Terminated		 CEPNone listed
Dec 20, 2012Beckman Coulter Inc.
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoass
Terminated		 CEPK940549
Jan 11, 2007Abbott Laboratories MPG
ARCHITECT LH Reagent, each kit contains bottles of Anti-Beta LH coated Microparticles and bottles of Anti-Alpha LH acridinium-labeled Conjugate; list numbers 6C25-22 (4 x 100 tests), 6C25-27(1 x 100 t
Terminated		 CEPNone listed

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