CEP · Class I · 21 CFR 862.1485

FDA Product Code CEP: Radioimmunoassay, Luteinizing Hormone

Leading manufacturers include Diagnostic Products Corp., Unipath , Ltd. and Nichols Institute Diagnostics.

143
Total
143
Cleared
72d
Avg days
1977
Since
143 devices
25–48 of 143
Cleared Oct 25, 1994
PRO-STEP LH OVULATION PREDICTION TEST
K943252
Disease Detection International, Inc.
Chemistry · 111d
Cleared Oct 20, 1994
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
K943996
Dupont Medical Products
Toxicology · 65d
Cleared Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 96d
Cleared Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared May 26, 1993
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394
Syva Co.
Chemistry · 156d
Cleared May 26, 1993
COBAS CORE LH EIA
K930306
Roche Diagnostic Systems, Inc.
Chemistry · 125d
Cleared Apr 08, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176
Vitek Systems, Inc.
Chemistry · 28d
Cleared Mar 11, 1992
LH GEN III SELF-TEST/CONCEIVE
K920160
Quidel Corp.
Chemistry · 57d
Cleared Mar 02, 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504
Medix Biotech, Inc.
Chemistry · 26d
Cleared Nov 07, 1991
OPUS(R) LH TEST SYSTEM
K913938
Pb Diagnostic Systems, Inc.
Toxicology · 65d
Cleared Feb 04, 1991
CIBA CORNING ACS LH IMMUNOASSAY
K910198
Ciba Corning Diagnostics Corp.
Chemistry · 19d
Cleared Oct 12, 1990
MILENIA (TM) LH
K902786
Diagnostic Products Corp.
Chemistry · 108d
Cleared Jun 28, 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398
Ciba Corning Diagnostics Corp.
Chemistry · 29d
Cleared Apr 03, 1990
ENZYMUN TEST(R) LH
K900779
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Mar 01, 1990
FIAGEN(TM) HLH.S
K900621
Cyberfluor, Inc.
Chemistry · 21d
Cleared Jan 30, 1990
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT
K896642
Medix Biotech, Inc.
Chemistry · 67d
Cleared Oct 31, 1989
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT
K895094
Hybritech, Inc.
Chemistry · 78d
Cleared Oct 12, 1989
CLEARPLAN EASY
K894579
Unipath , Ltd.
Chemistry · 80d
Cleared Aug 15, 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 53d
Cleared Jun 20, 1989
SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY
K893605
Serono-Baker Diagnostics, Inc.
Chemistry · 41d
Cleared Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
K890510
Abbott Laboratories
Chemistry · 51d
Cleared Mar 08, 1989
DELFIA HLH SPEC KIT
K883814
Pharmacia, Inc.
Chemistry · 181d
Cleared Dec 22, 1988
COTUBE LH IRMA ASSAY
K884498
Bio-Rad
Chemistry · 57d
Cleared Dec 19, 1988
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
K883530
Tambrands, Inc.
Chemistry · 123d