CEP · Class I · 21 CFR 862.1485

FDA Product Code CEP: Radioimmunoassay, Luteinizing Hormone

Leading manufacturers include Diagnostic Products Corp., Nichols Institute Diagnostics and Pcl-Ria, Inc..

143
Total
143
Cleared
72d
Avg days
1977
Since
143 devices
25–48 of 143
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 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 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
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138
Abbott Laboratories
Chemistry · 60d
Cleared Aug 04, 1988
PHASE II LH KIT
K882252
Vitek Systems, Inc.
Chemistry · 65d
Cleared Jul 28, 1988
AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
K880933
Amersham Corp.
Chemistry · 143d
Cleared Apr 18, 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124
Nichols Institute Diagnostics
Chemistry · 33d
Cleared Dec 30, 1987
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032
Diagnostic Products Corp.
Chemistry · 89d
Cleared Nov 25, 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584
Warner-Lambert Co.
Chemistry · 287d
Cleared Oct 07, 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668
Medix Biotech, Inc.
Chemistry · 27d
Cleared Oct 02, 1987
ANSWER OVULATION TEST KIT
K871241
Armkel, LLC
Chemistry · 189d
Cleared Sep 14, 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052
American Dade
Chemistry · 41d
Cleared Aug 25, 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131
Hybritech, Inc.
Chemistry · 82d
Cleared Aug 05, 1987
CLEARPLAN
K871332
Unipath , Ltd.
Chemistry · 124d