Product code CHP
- Device name
- Radioimmunoassay, Estradiol
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1260
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | Ibl GmbH | 2004-09-24 |
| K973901 | 17 B-ESTRADIOL (ELISA) | Kmi Diagnostics, Inc. | 1997-11-24 |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | 1997-10-31 |
| K970386 | ACS ESTADIOL-6 II | Chiron Diagnostics Corp. | 1997-06-04 |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-03-18 |
| K970126 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) | Bio-Rad Laboratories, Inc. | 1997-02-25 |
| K965109 | ELECSYS ESTRADIOL ASSAY | Boehringer Mannheim Corp. | 1997-02-18 |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Biomerieux Vitek, Inc. | 1996-02-06 |
| K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY | Ciba Corning Diagnostics Corp. | 1995-12-13 |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | Diagnostic Systems Laboratories, Inc. | 1995-10-02 |
| K951360 | ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1995-05-02 |
| K946199 | AURAFLEX(R) ESTRADIOL | Organon Teknika Corp. | 1995-04-03 |
| K943193 | COAT-A-COUNT(R) ESTRADIOL-6 | Diagnostic Products Corp. | 1995-02-23 |
| K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT | Incstar Corp. | 1994-09-07 |
| K932926 | IMMULITE ESTRADIOL | Diagnostic Products Corp. | 1994-01-10 |
| K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 |
| K932084 | AIA-PACK E2 ASSAY | Tosoh Medics, Inc. | 1993-11-09 |
| K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1993-10-22 |
| K933066 | OPUS ESTRADIOL | Pb Diagnostic Systems, Inc. | 1993-09-08 |
| K931740 | COTUBE ESTRADIOL RADIOIMMUNOASSAY | Bio-Rad | 1993-08-16 |
| K925498 | VIDAS ESTRADIOL (E2) ASSAY | Biomerieux Vitek, Inc. | 1993-02-12 |
| K920047 | IMX ESTRADIOL | Abbott Laboratories | 1992-02-18 |
| K913162 | ENZYMUN-TEST ESTRADIOL | Boehringer Mannheim Corp. | 1991-09-27 |
| K912917 | MILENIA ESTRADIOL | Diagnostic Products Corp. | 1991-07-30 |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | 1991-07-25 |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | Serono-Baker Diagnostics, Inc. | 1991-05-28 |
| K910249 | STRATUS ESTRADIOL FLUOREMETRIC ENZYME | Baxter Healthcare Corp | 1991-02-13 |
| K902358 | MODIFIED DELFIA ESTRADIOL KIT | Pharmacia, Inc. | 1990-06-18 |
| K896145 | ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-12-27 |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | Amersham Corp. | 1989-12-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336218389 | Elecsys Estradiol III | Roche Diagnostics GmbH | 2026-06-01 |
| 00850054026682 | AccuDiag™ Estradiol ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| 07613336232125 | Ionify Steroids 1 | Roche Diagnostics GmbH | 2025-12-11 |
| 14560189216621 | CL AIA-PACK hs-E2 TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 24560189216628 | CL AIA-PACK hs-E2 TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 04048474046649 | Estradiol (serum) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-21 |
| 04049325030541 | 17beta-Estradiol Saliva Luminescence Immunoassay | IBL International GmbH | 2023-09-29 |
| 04049325030534 | 17beta-Estradiol Saliva Luminescence Immunoassay | IBL International GmbH | 2023-09-29 |
| 00859410006245 | Salimetrics | SALIMETRICS, LLC | 2023-09-26 |
| 00859410006252 | Salimetrics | SALIMETRICS, LLC | 2023-09-26 |
| 04048474061451 | Salivary Estradiol HS ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474053494 | Estradiol | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474041880 | Salivary Estradiol ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474043990 | Estradiol Sensitive ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-31 |
| 04048474026931 | Estradiol ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239041883 | Salivary Estradiol ELISA | DRG International Inc | 2023-08-26 |
| 00840239053497 | Estradiol | DRG International Inc | 2023-08-26 |
| 00840239061454 | Salivary Estradiol HS ELISA | DRG International Inc | 2023-08-26 |
| 00840239043993 | Estradiol Sensitive ELISA | DRG International Inc | 2023-08-25 |
| 24560189210381 | ST AIA-PACK E2 | TOSOH CORPORATION | 2019-07-24 |
| 24560189212736 | ST AIA-PACK hsE2 | TOSOH CORPORATION | 2019-07-24 |
| 14560189212753 | ST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 14560189211282 | ST AIA-PACK E2 CALIBRATOR SET | TOSOH CORPORATION | 2019-07-24 |
| 14560189211275 | AIA-PACK E2 Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 04560189212756 | ST AIA-PACK hsE2 SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 04560189211285 | ST AIA-PACK E2 CALIBRATOR SET | TOSOH CORPORATION | 2019-07-24 |
| 04560189211278 | AIA-PACK E2 Sample Diluting Solution | TOSOH CORPORATION | 2019-07-24 |
| 14560189212739 | ST AIA-PACK hsE2 | TOSOH CORPORATION | 2019-07-24 |
| 14560189210384 | ST AIA-PACK E2 | TOSOH CORPORATION | 2019-07-24 |
| 04015630939671 | Elecsys Estradiol III | Roche Diagnostics GmbH | 2017-04-14 |