510(k) K955647
- Device
- VIDAS ESTRADIOL II (E2II) ASSAY
- Applicant
- BIOMERIEUX VITEK, INC.
- 510(k) number
- K955647
- Product code
- CHP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-02-06
- Date received
- 1995-12-12
- Regulation
- 862.1260
- Classification name
- Radioimmunoassay, Estradiol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TERRY MCGOVERN
- Address
- 1022 Hingham St. Rockland MA US 02370 02370
FDA Registration Numbers#
- 3004192065
- 3003760091
- 2432235
- 3007111389
- 3005333358
- 3006198300
- 3022178699
- 3009984016
- 3002806944
- 3011989923
- 9680746
- 3009491259
- 3000308930
- 3009518015
- 8010132
- 3002800697
- 3002809144
- 8020790
- 2032682
- 3017894300
- 3002642396
- 3005094123
- 2029372
- 9610126
- 2245285
- 8020888
- 1036362
- 3017379203
- 3017019647
- 8031673
- 2032839
- 2020726
- 1827821
- 2250051
- 8023018
- 3003559191
- 2122870
- 3009335633
- 3005542422
- 3005529799
- 9710337
- 9612316
- 1222302
- 2182595
- 2133982
- 2419955
- 3003741796
- 1219913
- 1319681
Source Documents#
Other 510(k) Records For Product Code CHP #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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