CHP · Class I · 21 CFR 862.1260

FDA Product Code CHP: Radioimmunoassay, Estradiol

Leading manufacturers include Diagnostic Products Corp., Serono-Baker Diagnostics, Inc. and Diagnostic Systems Laboratories, Inc..

50
Total
50
Cleared
72d
Avg days
1979
Since
50 devices
25–48 of 50
Cleared Jul 25, 1991
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)
K912318
Serono-Baker Diagnostics, Inc.
Chemistry · 62d
Cleared May 28, 1991
SR1 ESTRADIOL ENZYME IMMUNOASSAY
K911396
Serono-Baker Diagnostics, Inc.
Chemistry · 60d
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 27, 1989
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY
K896145
Serono-Baker Diagnostics, Inc.
Chemistry · 65d
Cleared Dec 12, 1989
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081
K896270
Amersham Corp.
Chemistry · 42d
Cleared Mar 08, 1989
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
K890645
Serono-Baker Diagnostics, Inc.
Chemistry · 28d
Cleared Nov 16, 1988
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)
K884105
Amersham Corp.
Chemistry · 48d
Cleared Jul 01, 1988
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT
K882343
Terumo Medical Corp.
Chemistry · 24d
Cleared Jun 24, 1988
DELFIA ESTRADIOL KIT
K882173
Pharmacia, Inc.
Chemistry · 31d
Cleared Feb 18, 1988
DSL ACTIVE ESTRADIOL RIA (DSL #4300)
K873550
Diagnostic Systems Laboratories, Inc.
Chemistry · 171d
Cleared Jun 08, 1987
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
K870405
Diagnostic Systems Laboratories, Inc.
Chemistry · 125d
Cleared Aug 19, 1986
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603
Diagnostic Products Corp.
Chemistry · 42d
Cleared Jun 27, 1986
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K861361
Serono Diagnostics, Inc.
Chemistry · 78d
Cleared Aug 19, 1985
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY
K853208
Travenol Laboratories, S.A.
Chemistry · 19d
Cleared Jun 25, 1984
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT
K841947
Sorin Biomedica, Fiat, USA, Inc.
Chemistry · 42d
Cleared Mar 23, 1984
COAT-A-COUNT ESTRADIOL KIT
K840051
Diagnostic Products Corp.
Chemistry · 77d
Cleared Mar 09, 1984
LEECO E2 QUANT DIAG. TEST KIT
K834586
Leeco Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 04, 1982
ESTRADIOL KIT BY RIA
K820329
Immuchem Corp.
Chemistry · 24d