Atlas FDA

CHP

50 FDA 510(k) clearances · Product code

60 daysmedian time to decision
177 days90th percentile
50clearances measured

FDA profile

Official device name
Radioimmunoassay, Estradiol
Device class
Class I (low risk)
Regulation
21 CFR 862.1260
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 43 · 2022: 61 · 2023: 60 · 2024: 65 · 2025: 86 · 2026: 42
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (K041349)Ibl GmbH2004-09-24
17 B-ESTRADIOL (ELISA) (K973901)Kmi Diagnostics, Inc.1997-11-24
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K973743)Beckman Instruments, Inc.1997-10-31
ACS ESTADIOL-6 II (K970386)Chiron Diagnostics Corp.1997-06-04
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) (K970643)Johnson & Johnson Clinical Diagnostics, Inc.1997-03-18
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (K970126)Bio-Rad Laboratories, Inc.1997-02-25
ELECSYS ESTRADIOL ASSAY (K965109)Boehringer Mannheim Corp.1997-02-18
VIDAS ESTRADIOL II (E2II) ASSAY (K955647)Biomerieux Vitek, Inc.1996-02-06
CIBA CORNING ACS ESTRADIOL-6 ASSAY (K954697)Ciba Corning Diagnostics Corp.1995-12-13
ULTRA-SENSITIVE ESTRADIOL (K953605)Diagnostic Systems Laboratories, Inc.1995-10-02
ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K951360)Bayer Corp.1995-05-02
AURAFLEX(R) ESTRADIOL (K946199)Organon Teknika Corp.1995-04-03
COAT-A-COUNT(R) ESTRADIOL-6 (K943193)Diagnostic Products Corp.1995-02-23
CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT (K941168)Incstar Corp.1994-09-07
IMMULITE ESTRADIOL (K932926)Diagnostic Products Corp.1994-01-10
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY (K932715)Ciba Corning Diagnostics Corp.1993-12-03
AIA-PACK E2 ASSAY (K932084)Tosoh Medics, Inc.1993-11-09
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY (K933464)Baxter Diagnostics, Inc.1993-10-22
OPUS ESTRADIOL (K933066)Pb Diagnostic Systems, Inc.1993-09-08
COTUBE ESTRADIOL RADIOIMMUNOASSAY (K931740)Bio-Rad1993-08-16
VIDAS ESTRADIOL (E2) ASSAY (K925498)Biomerieux Vitek, Inc.1993-02-12
IMX ESTRADIOL (K920047)Abbott Laboratories1992-02-18
ENZYMUN-TEST ESTRADIOL (K913162)Boehringer Mannheim Corp.1991-09-27
MILENIA ESTRADIOL (K912917)Diagnostic Products Corp.1991-07-30
ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) (K912318)Serono-Baker Diagnostics, Inc.1991-07-25
SR1 ESTRADIOL ENZYME IMMUNOASSAY (K911396)Serono-Baker Diagnostics, Inc.1991-05-28
STRATUS ESTRADIOL FLUOREMETRIC ENZYME (K910249)Baxter Healthcare Corp1991-02-13
MODIFIED DELFIA ESTRADIOL KIT (K902358)Pharmacia, Inc.1990-06-18
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY (K896145)Serono-Baker Diagnostics, Inc.1989-12-27
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (K896270)Amersham Corp.1989-12-12
ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT (K890645)Serono-Baker Diagnostics, Inc.1989-03-08
AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) (K884105)Amersham Corp.1988-11-16
TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT (K882343)Terumo Medical Corp.1988-07-01
DELFIA ESTRADIOL KIT (K882173)Pharmacia, Inc.1988-06-24
DSL ACTIVE ESTRADIOL RIA (DSL #4300) (K873550)Diagnostic Systems Laboratories, Inc.1988-02-18
DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) (K870405)Diagnostic Systems Laboratories, Inc.1987-06-08
DOUBLE ANTIBODY ESTRADIOL RIA KIT (K862603)Diagnostic Products Corp.1986-08-19
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE (K861361)Serono Diagnostics, Inc.1986-06-27
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS (K853866)Pantex, Div. Bio-Analysis, Inc.1985-10-15
125I ESTRADIOL DIRECT RADIOIMMUNOASSAY (K853208)Travenol Laboratories, S.A.1985-08-19
ESTRADIOL DIRECT RIA KIT (K851540)Biotecx Laboratories, Inc.1985-06-06
ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT (K841947)Sorin Biomedica, Fiat, USA, Inc.1984-06-25
COAT-A-COUNT ESTRADIOL KIT (K840051)Diagnostic Products Corp.1984-03-23
LEECO E2 QUANT DIAG. TEST KIT (K834586)Leeco Diagnostics, Inc.1984-03-09
ESTRADIOL KIT BY RIA (K820329)Immuchem Corp.1982-03-04
ESTRIOL RADIOIMMUNOASSAY TEST KIT (K810695)Serono Laboratories, Inc.1981-03-31
17B ESTRADIOL (K810204)Pantex, Div. Bio-Analysis, Inc.1981-03-27
NORDICLAB ESTRADIOL RIA TEST (K800920)Nordiclab Intl.1980-05-14
ESTRADIOL KIT BY RIA (K791652)Radioassay Systems Laboratories, Inc.1979-09-27
ESTRADIOL RIA KIT (K790679)Serono Laboratories, Inc.1979-05-23

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