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
73–96 of 143
Cleared Apr 29, 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984
Hybritech, Inc.
Chemistry · 43d
Cleared Mar 17, 1986
SUCROSEP LUTEINIZING HORMONE (LH) IRMA
K860308
Boots-Celltech Diagnostics, Inc.
Chemistry · 48d
Cleared Feb 28, 1986
DELFIA TM HLH KIT
K855173
Lkb Instruments, Inc.
Chemistry · 64d
Cleared Jan 07, 1986
LEE-BEAD BETA LH (EIA)
K854838
Leeco Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 29, 1985
QUIDEL QUEST OVULATION TEST
K852146
Quidel Corp.
Chemistry · 74d
Cleared Apr 10, 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104
Amersham Corp.
Chemistry · 22d
Cleared Sep 04, 1984
LH RIA
K842445
Syncor Intl. Corp.
Chemistry · 75d
Cleared Mar 23, 1984
MICROMEDIC LH & FSH RIA KIT
K840188
Micromedic Systems
Chemistry · 65d
Cleared Mar 19, 1984
LH QUIK RIA KIT
K840174
Pacific Biotech, Inc.
Chemistry · 62d
Cleared Jan 13, 1984
LH RIA
K833854
Syncor Intl. Corp.
Chemistry · 70d
Cleared Dec 20, 1983
RIANEN LUTEINIZING HORMONE RIA KIT
K833376
New England Nuclear
Chemistry · 83d
Cleared Dec 28, 1982
GAMMADAB LH RADIO-KIT #CA-1508
K823476
Clinical Assays, Inc.
Chemistry · 36d
Cleared Sep 13, 1982
LH (125I) RADIOIMMUNOASSAY
K822288
Corning Medical & Scientific
Chemistry · 45d
Cleared May 28, 1982
QUANTIMUNE HLH RIA
K821346
Bio-Rad
Chemistry · 23d
Cleared Apr 16, 1982
LH RADIOIMMUNOASSAY TEST SYSTEM
K820760
Monobind
Chemistry · 25d
Cleared Apr 09, 1982
AMERLEX LH RIA KIT (CODE IM2081)
K820753
Amersham Corp.
Chemistry · 21d
Cleared Mar 25, 1982
LUTEINIZING HORMONE KIT
K820357
Pcl-Ria, Inc.
Chemistry · 44d
Cleared Dec 22, 1981
SHARIA-LH RIA KIT FOR QUANTITATION HORMO
K813213
Intl. Immunoassay Laboratories, Inc.
Chemistry · 43d
Cleared May 08, 1981
LUTEINIZING HORMONE DIRECT RIA KIT 125/I
K811024
Immunalysis Corporation
Chemistry · 23d
Cleared Mar 31, 1981
LEECO LH-QUANT DIAGNOSTIC KIT
K810662
Leeco Diagnostics, Inc.
Chemistry · 20d
Cleared Mar 31, 1981
LUTEINIZING HORMONE
K810741
Pcl-Ria, Inc.
Chemistry · 12d
Cleared Mar 31, 1981
LUTENIZING HORMONES
K810754
Pcl-Ria, Inc.
Chemistry · 11d
Cleared Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302
Bio-Rad
Chemistry · 20d
Cleared Jan 21, 1981
LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
K803278
Immuno Nuclear Corp.
Chemistry · 23d