CHP · Class I · 21 CFR 862.1260

FDA Product Code CHP: Radioimmunoassay, Estradiol

Leading manufacturers include Diagnostic Products Corp., Diagnostic Systems Laboratories, Inc. and Boehringer Mannheim Corp..

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 Mar 18, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
K970643
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 26d
Cleared Feb 25, 1997
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
K970126
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 18, 1997
ELECSYS ESTRADIOL ASSAY
K965109
Boehringer Mannheim Corp.
Chemistry · 60d
Cleared Feb 06, 1996
VIDAS ESTRADIOL II (E2II) ASSAY
K955647
Biomerieux Vitek, Inc.
Chemistry · 56d
Cleared Dec 13, 1995
CIBA CORNING ACS ESTRADIOL-6 ASSAY
K954697
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Oct 02, 1995
ULTRA-SENSITIVE ESTRADIOL
K953605
Diagnostic Systems Laboratories, Inc.
Chemistry · 61d
Cleared May 02, 1995
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM
K951360
Bayer Corp.
Chemistry · 36d
Cleared Apr 03, 1995
AURAFLEX(R) ESTRADIOL
K946199
Organon Teknika Corp.
Chemistry · 104d
Cleared Feb 23, 1995
COAT-A-COUNT(R) ESTRADIOL-6
K943193
Diagnostic Products Corp.
Chemistry · 233d
Cleared Sep 07, 1994
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT
K941168
Incstar Corp.
Chemistry · 177d
Cleared Jan 10, 1994
IMMULITE ESTRADIOL
K932926
Diagnostic Products Corp.
Chemistry · 209d
Cleared Dec 03, 1993
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715
Ciba Corning Diagnostics Corp.
Chemistry · 182d
Cleared Nov 09, 1993
AIA-PACK E2 ASSAY
K932084
Tosoh Medics, Inc.
Chemistry · 193d
Cleared Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
K933464
Baxter Diagnostics, Inc.
Chemistry · 98d
Cleared Sep 08, 1993
OPUS ESTRADIOL
K933066
Pb Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Aug 16, 1993
COTUBE ESTRADIOL RADIOIMMUNOASSAY
K931740
Bio-Rad
Chemistry · 131d
Cleared Feb 12, 1993
VIDAS ESTRADIOL (E2) ASSAY
K925498
Biomerieux Vitek, Inc.
Chemistry · 105d
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 Jun 18, 1990
MODIFIED DELFIA ESTRADIOL KIT
K902358
Pharmacia, Inc.
Chemistry · 20d
Cleared Dec 12, 1989
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270
Amersham Corp.
Chemistry · 42d

About Product Code CHP - Regulatory Context