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
FDA 510(k) Cleared Radioimmunoassay, Luteinizing Hormone Devices (Product Code CEP)
143 devices
Cleared
Nov 05, 2002
INSTANT-VIEW LH OVULATION PREDICTING TEST
Alfa Scientific Designs, Inc.
Chemistry
71d
Cleared
Feb 19, 2002
CLEARPLANE EASY OVULATION TEST
Unipath , Ltd.
Chemistry
90d
Cleared
Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
ACON Laboratories, Inc.
Chemistry
37d
Cleared
Mar 22, 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
Phamatech
Chemistry
55d
Cleared
Jun 25, 1998
CLEARPLAN EASY OVULATION TEST
Unipath , Ltd.
Chemistry
79d
Cleared
Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
Armkel, LLC
Chemistry
54d
Cleared
Feb 20, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry
70d
Cleared
Jan 24, 1997
ELECSYS LH ASSAY
Boehringer Mannheim Corp.
Chemistry
63d
Cleared
Nov 29, 1996
OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST
Princeton BioMeditech Corp.
Toxicology
74d
Cleared
Aug 23, 1996
OPUS HLH
Behring Diagnostics, Inc.
Chemistry
31d
Cleared
Jun 21, 1996
ACS LH2 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
Chemistry
24d
Cleared
Apr 05, 1996
ACTIVE LH IRMA
Diagnostic Systems Laboratories, Inc.
Chemistry
16d
Cleared
Oct 03, 1995
FIRST RESPONSE OVULATION PREDICTOR TEST
Armkel, LLC
Chemistry
63d
Cleared
Aug 23, 1995
CONCEIVE OVULATION PREDICTOR
Quidel Corp.
Chemistry
54d
Cleared
May 15, 1995
COAT-A-COUNT LH IRMA
Diagnostic Products Corp.
Chemistry
28d
Cleared
Apr 05, 1995
CHEMILUMINESCENCE LH
Nichols Institute Diagnostics
Chemistry
532d
Cleared
Oct 20, 1994
DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
Dupont Medical Products
Toxicology
65d
Cleared
Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
96d
Cleared
Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
Bio-Rad Laboratories, Inc.
Chemistry
58d
Cleared
May 26, 1993
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
Syva Co.
Chemistry
156d
Cleared
May 26, 1993
COBAS CORE LH EIA
Roche Diagnostic Systems, Inc.
Chemistry
125d
Cleared
Apr 08, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
Vitek Systems, Inc.
Chemistry
28d
Cleared
Mar 11, 1992
LH GEN III SELF-TEST/CONCEIVE
Quidel Corp.
Chemistry
57d
Cleared
Mar 02, 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
Medix Biotech, Inc.
Chemistry
26d