FDA Product Code CEP: Radioimmunoassay, Luteinizing Hormone
Leading manufacturers include Diagnostic Products Corp., Bio-Rad and Abbott Laboratories.
143
Total
143
Cleared
72d
Avg days
1977
Since
FDA 510(k) Cleared Radioimmunoassay, Luteinizing Hormone Devices (Product Code CEP)
143 devices
Cleared
Jan 24, 1997
ELECSYS LH ASSAY
Boehringer Mannheim Corp.
Chemistry
63d
Cleared
Aug 23, 1996
OPUS HLH
Behring Diagnostics, Inc.
Chemistry
31d
Cleared
May 15, 1995
COAT-A-COUNT LH IRMA
Diagnostic Products Corp.
Chemistry
28d
Cleared
Sep 07, 1994
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
96d
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
Oct 12, 1990
MILENIA (TM) LH
Diagnostic Products Corp.
Chemistry
108d
Cleared
Apr 03, 1990
ENZYMUN TEST(R) LH
Boehringer Mannheim Corp.
Chemistry
42d
Cleared
Aug 15, 1989
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry
53d
Cleared
Mar 24, 1989
ABBOTT OVULATION PREDICTOR TEST
Abbott Laboratories
Chemistry
51d
Cleared
Dec 22, 1988
COTUBE LH IRMA ASSAY
Bio-Rad
Chemistry
57d
Cleared
Nov 29, 1988
ABBOTT IMX LH
Abbott Laboratories
Chemistry
60d
Cleared
Dec 30, 1987
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
Diagnostic Products Corp.
Chemistry
89d
Cleared
Sep 14, 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
American Dade
Chemistry
41d
Cleared
Feb 06, 1987
DPC COAT-A-COUNT IRMA LH KIT
Diagnostic Products Corp.
Chemistry
120d
Cleared
Nov 13, 1986
TERUMO SENSIBEAD(TM) EIA HLH KIT
Terumo Medical Corp.
Chemistry
36d
Cleared
May 28, 1982
QUANTIMUNE HLH RIA
Bio-Rad
Chemistry
23d
Cleared
Feb 25, 1981
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
Bio-Rad
Chemistry
20d
Cleared
Sep 17, 1979
125I LEUTINIZING HORMONE RIA KIT
Diagnostic Products Corp.
Chemistry
48d