CHP · Class I · 21 CFR 862.1260

FDA Product Code CHP: Radioimmunoassay, Estradiol

Leading manufacturers include Diagnostic Products Corp., Boehringer Mannheim Corp. and Travenol Laboratories, S.A..

50
Total
50
Cleared
72d
Avg days
1979
Since

FDA 510(k) Cleared Radioimmunoassay, Estradiol Devices (Product Code CHP)

50 devices
1–24 of 50
Cleared Oct 31, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973743
Beckman Instruments, Inc.
Chemistry · 30d
Cleared Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
K965109
Boehringer Mannheim Corp.
Chemistry · 60d
Cleared Feb 23, 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193
Diagnostic Products Corp.
Chemistry · 233d
Cleared Jan 10, 1994
IMMULITE ESTRADIOL
K932926
Diagnostic Products Corp.
Chemistry · 209d
Cleared Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740
Bio-Rad
Chemistry · 131d
Cleared Feb 18, 1992
IMX ESTRADIOL
K920047
Abbott Laboratories
Chemistry · 43d
Cleared Sep 27, 1991
ENZYMUN-TEST ESTRADIOL
K913162
Boehringer Mannheim Corp.
Chemistry · 72d
Cleared Jul 30, 1991
MILENIA ESTRADIOL
K912917
Diagnostic Products Corp.
Chemistry · 27d
Cleared Feb 13, 1991
STRATUS ESTRADIOL FLUOREMETRIC ENZYME
K910249
Baxter Healthcare Corp
Chemistry · 22d
Cleared Aug 19, 1986
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603
Diagnostic Products Corp.
Chemistry · 42d
Cleared Aug 19, 1985
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208
Travenol Laboratories, S.A.
Chemistry · 19d
Cleared Mar 23, 1984
COAT-A-COUNT ESTRADIOL KIT
K840051
Diagnostic Products Corp.
Chemistry · 77d

About Product Code CHP - Regulatory Context