FDA Product Code CEP: Radioimmunoassay, Luteinizing Hormone
Leading manufacturers include Diagnostic Products Corp., Leeco Diagnostics, Inc. and Unipath , Ltd..
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
May 25, 1999
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
Selfcare, Inc.
Chemistry
34d
Cleared
May 25, 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
Selfcare, Inc.
Chemistry
28d
Cleared
Mar 22, 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
Phamatech
Chemistry
55d
Cleared
Nov 18, 1998
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
Syntron Bioresearch, Inc.
Chemistry
75d
Cleared
Jun 25, 1998
CLEARPLAN EASY OVULATION TEST
Unipath , Ltd.
Chemistry
79d
Cleared
Feb 02, 1998
DBEST ONE-STEP OVULATION TEST
Ameritek, Inc.
Chemistry
63d
Cleared
Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
Armkel, LLC
Chemistry
54d
Cleared
Mar 18, 1997
EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT
Excel Scientific, Inc.
Chemistry
39d
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
Jan 22, 1997
SEALITE SCIENCES, INC. AQUALITE LH
Sealite Sciences, Inc.
Chemistry
44d
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 23, 1996
MINICLINIC OVULATION PREDICTOR
Vanguard Biomedical Corp.
Chemistry
97d
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
Jul 11, 1995
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT
Syntron Bioresearch, Inc.
Chemistry
99d
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