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
49–72 of 143
Cleared Nov 29, 1988
ABBOTT IMX LH
K884138
Abbott Laboratories
Chemistry · 60d
Cleared Aug 08, 1988
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA
K882340
Serono Diagnostics, Inc.
Chemistry · 62d
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
SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY
K880758
Boots-Celltech Diagnostics, Inc.
Chemistry · 53d
Cleared Apr 18, 1988
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124
Nichols Institute Diagnostics
Chemistry · 33d
Cleared Jan 11, 1988
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K874624
Cyberfluor, Inc.
Chemistry · 62d
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 29, 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186
Serono Diagnostics, Inc.
Chemistry · 48d
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
Cleared Aug 05, 1987
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE
K872727
Serono Diagnostics, Inc.
Chemistry · 28d
Cleared Jun 11, 1987
MICROCHECK LH OVULATION TEST
K871602
Syntron Bioresearch, Inc.
Chemistry · 48d
Cleared Feb 06, 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934
Diagnostic Products Corp.
Chemistry · 120d
Cleared Feb 04, 1987
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE
K863442
United Biotech, Inc.
Chemistry · 152d
Cleared Nov 24, 1986
LUTEINIZING HORMONE (LH-IRMA) RIA KIT
K864144
Immuchem Corp.
Chemistry · 33d
Cleared Nov 13, 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
K863929
Terumo Medical Corp.
Chemistry · 36d
Cleared Oct 16, 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679
Nichols Institute Diagnostics
Chemistry · 27d
Cleared Sep 16, 1986
RIGHT-DAY OVULATION HOME TEST
K861354
Leeco Diagnostics, Inc.
Chemistry · 159d
Cleared Jul 29, 1986
RIGHT-DAY URINARY LH (EIA)
K860538
Leeco Diagnostics, Inc.
Chemistry · 167d