CGI · Class I · 21 CFR 862.1265

FDA Product Code CGI: Radioimmunoassay, Estriol

Leading manufacturers include Bio-Rad, Diagnostic Products Corp. and Bd Becton Dickinson Vacutainer Systems Preanalytic.

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 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 Jan 18, 1985
TDX TOTAL ESTRIOL
K844511
Abbott Laboratories
Chemistry · 59d
Cleared Dec 15, 1982
FREE & TOTAL ESTRIOL KIT
K823202
Diagnostic Products Corp.
Chemistry · 50d
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 Dec 22, 1980
QUANTIMUNE E3 RIA
K802944
Bio-Rad
Toxicology · 33d
Cleared Sep 16, 1980
ARIA II 125- I-ESTRIOL SYSTEM
K801735
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 53d
Cleared Jan 03, 1979
RIA, QUANTIMUNE E3
K781850
Bio-Rad
Chemistry · 62d
Cleared Jun 02, 1977
RIA-120 AND ESTRIOL REAGENT SYSTEM
K770465
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 84d

About Product Code CGI - Regulatory Context