CGI · Class I · 21 CFR 862.1265

FDA Product Code CGI: Radioimmunoassay, Estriol

Leading manufacturers include Amersham Corp., Bio-Rad and Diagnostic Products Corp..

42
Total
42
Cleared
58d
Avg days
1977
Since

FDA 510(k) Cleared Radioimmunoassay, Estriol Devices (Product Code CGI)

42 devices
1–24 of 42
Cleared Mar 03, 1998
UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K974721
Bayer Corp.
Chemistry · 75d
Cleared Aug 23, 1996
ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA
K962875
Diagnostic Systems Laboratories, Inc.
Chemistry · 30d
Cleared May 15, 1996
ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL
K955356
Diagnostic Systems Laboratories, Inc.
Chemistry · 176d
Cleared Dec 19, 1994
COAT-A-COUNT FREE ESTRIOL
K932989
Diagnostic Products Corp.
Chemistry · 549d
Cleared Mar 23, 1992
AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL
K920576
Eastman Kodak Company
Chemistry · 42d
Cleared Aug 22, 1990
MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT
K903359
Immunotech Corp.
Chemistry · 28d
Cleared Apr 28, 1986
IMMPULSE FREE ESTRIOL ASSAY REAGENTS
K860900
Sclavo, Inc.
Chemistry · 49d
Cleared Jan 18, 1985
TDX TOTAL ESTRIOL
K844511
Abbott Laboratories
Chemistry · 59d
Cleared Dec 11, 1984
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED
K844408
Amersham Corp.
Chemistry · 27d
Cleared Apr 18, 1984
ENDAB ESTRIOL UNCONJUGATED
K840902
Immunotech Corp.
Chemistry · 50d
Cleared Dec 15, 1982
FREE & TOTAL ESTRIOL KIT
K823202
Diagnostic Products Corp.
Chemistry · 50d
Cleared Oct 26, 1982
MICROMEDIC ESTRIOL RIA KIT
K822578
Micromedic Systems
Chemistry · 62d
Cleared Sep 30, 1982
DSL 1400
K822314
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Jun 24, 1982
AUTOPAK ESTRIOL TEST DELIVERY SYSTEM
K821678
Micromedic Systems
Chemistry · 16d
Cleared Apr 06, 1982
QUANTIMUNE ESTRIOL RIA
K820728
Bio-Rad
Chemistry · 20d
Cleared Jan 18, 1982
COAT-A-COUNT FREE & TOTAL ESTRIOL KIT
K812768
Diagnostic Products Corp.
Chemistry · 105d
Cleared Jul 10, 1981
QUANTIMUNE ESTRIOL RIA
K811709
Bio-Rad
Chemistry · 23d
Cleared May 29, 1981
NATAL-TEC ESTRIOL
K811371
Armkel, LLC
Chemistry · 15d
Cleared Mar 31, 1981
AMERLEX ESTRIOL RIA KIT
K810667
Amersham Corp.
Chemistry · 19d
Cleared Dec 22, 1980
QUANTIMUNE E3 RIA
K802944
Bio-Rad
Toxicology · 33d
Cleared Oct 31, 1980
ESTRIOL-SQUIBB RIA KIT
K802455
E. R. Squibb & Sons, Inc.
Chemistry · 23d
Cleared Sep 16, 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 53d
Cleared Jan 21, 1980
TOTAL ESTRIOL RIA KIT
K800036
Amersham Corp.
Chemistry · 14d
Cleared Jan 03, 1979
RIA, QUANTIMUNE E3
K781850
Bio-Rad
Chemistry · 62d

About Product Code CGI - Regulatory Context