FDA Product Code
FDA Product Code CHP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1260
510(k) Clearances — 50 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | Ibl GmbH | 2004-09-24 | Traditional | PDF ↗ |
| K973901 | 17 B-ESTRADIOL (ELISA) | Kmi Diagnostics, Inc. | 1997-11-24 | Traditional | PDF ↗ |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 | Traditional | PDF ↗ |
| K970386 | ACS ESTADIOL-6 II | Chiron Diagnostics Corp. | 1997-06-04 | Traditional | PDF ↗ |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 | Traditional | PDF ↗ |
| K970126 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) | Bio-Rad Laboratories, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K965109 | ELECSYS ESTRADIOL ASSAY | Boehringer Mannheim Corp. | 1997-02-18 | Traditional | PDF ↗ |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Biomerieux Vitek, Inc. | 1996-02-06 | Traditional | PDF ↗ |
| K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY | Ciba Corning Diagnostics Corp. | 1995-12-13 | Traditional | PDF ↗ |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | Diagnostic Systems Laboratories, Inc. | 1995-10-02 | Traditional | PDF ↗ |
| K951360 | ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1995-05-02 | Traditional | PDF ↗ |
| K946199 | AURAFLEX(R) ESTRADIOL | Organon Teknika Corp. | 1995-04-03 | Traditional | PDF ↗ |
| K943193 | COAT-A-COUNT(R) ESTRADIOL-6 | Diagnostic Products Corp. | 1995-02-23 | Traditional | PDF ↗ |
| K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT | Incstar Corp. | 1994-09-07 | Traditional | PDF ↗ |
| K932926 | IMMULITE ESTRADIOL | Diagnostic Products Corp. | 1994-01-10 | Traditional | PDF ↗ |
| K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | Traditional | PDF ↗ |
| K932084 | AIA-PACK E2 ASSAY | Tosoh Medics, Inc. | 1993-11-09 | Traditional | PDF ↗ |
| K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1993-10-22 | Traditional | PDF ↗ |
| K933066 | OPUS ESTRADIOL | Pb Diagnostic Systems, Inc. | 1993-09-08 | Traditional | PDF ↗ |
| K931740 | COTUBE ESTRADIOL RADIOIMMUNOASSAY | Bio-Rad | 1993-08-16 | Traditional | PDF ↗ |
| K925498 | VIDAS ESTRADIOL (E2) ASSAY | Biomerieux Vitek, Inc. | 1993-02-12 | Traditional | PDF ↗ |
| K920047 | IMX ESTRADIOL | Abbott Laboratories | 1992-02-18 | Traditional | PDF ↗ |
| K913162 | ENZYMUN-TEST ESTRADIOL | Boehringer Mannheim Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K912917 | MILENIA ESTRADIOL | Diagnostic Products Corp. | 1991-07-30 | Traditional | PDF ↗ |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-07-25 | Traditional | PDF ↗ |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-28 | Traditional | PDF ↗ |
| K910249 | STRATUS ESTRADIOL FLUOREMETRIC ENZYME | Baxter Healthcare Corp | 1991-02-13 | Traditional | PDF ↗ |
| K902358 | MODIFIED DELFIA ESTRADIOL KIT | Pharmacia, Inc. | 1990-06-18 | Traditional | PDF ↗ |
| K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-12-27 | Traditional | PDF ↗ |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | Amersham Corp. | 1989-12-12 | Traditional | PDF ↗ |
| K890645 | ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT | Serono-Baker Diagnostics, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K884105 | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) | Amersham Corp. | 1988-11-16 | Traditional | PDF ↗ |
| K882343 | TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT | Terumo Medical Corp. | 1988-07-01 | Traditional | PDF ↗ |
| K882173 | DELFIA ESTRADIOL KIT | Pharmacia, Inc. | 1988-06-24 | Traditional | PDF ↗ |
| K873550 | DSL ACTIVE ESTRADIOL RIA (DSL #4300) | Diagnostic Systems Laboratories, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K870405 | DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) | Diagnostic Systems Laboratories, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K862603 | DOUBLE ANTIBODY ESTRADIOL RIA KIT | Diagnostic Products Corp. | 1986-08-19 | Traditional | PDF ↗ |
| K861361 | ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE | Serono Diagnostics, Inc. | 1986-06-27 | Traditional | PDF ↗ |
| K853866 | PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS | Pantex, Div. Bio-Analysis, Inc. | 1985-10-15 | Traditional | PDF ↗ |
| K853208 | 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY | Travenol Laboratories, S.A. | 1985-08-19 | Traditional | PDF ↗ |
| K851540 | ESTRADIOL DIRECT RIA KIT | Biotecx Laboratories, Inc. | 1985-06-06 | Traditional | PDF ↗ |
| K841947 | ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K840051 | COAT-A-COUNT ESTRADIOL KIT | Diagnostic Products Corp. | 1984-03-23 | Traditional | PDF ↗ |
| K834586 | LEECO E2 QUANT DIAG. TEST KIT | Leeco Diagnostics, Inc. | 1984-03-09 | Traditional | PDF ↗ |
| K820329 | ESTRADIOL KIT BY RIA | Immuchem Corp. | 1982-03-04 | Traditional | PDF ↗ |
| K810695 | ESTRIOL RADIOIMMUNOASSAY TEST KIT | Serono Laboratories, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810204 | 17B ESTRADIOL | Pantex, Div. Bio-Analysis, Inc. | 1981-03-27 | Traditional | PDF ↗ |
| K800920 | NORDICLAB ESTRADIOL RIA TEST | Nordiclab Intl. | 1980-05-14 | Traditional | PDF ↗ |
| K791652 | ESTRADIOL KIT BY RIA | Radioassay Systems Laboratories, Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K790679 | ESTRADIOL RIA KIT | Serono Laboratories, Inc. | 1979-05-23 | Traditional | PDF ↗ |
Product code CHP · Class I · Clinical Chemistry. Data: openFDA.