CHP · Radioimmunoassay, Estradiol
Clinical Chemistry · 21 CFR 862.1260 · Class 1
Overview
| Product Code | CHP |
|---|---|
| Device Name | Radioimmunoassay, Estradiol |
| Regulation | 21 CFR 862.1260 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 50)
Showing 20 most recent of 50 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | Ibl GmbH | Sep 24, 2004 | SESE |
| K973901 | 17 B-ESTRADIOL (ELISA) | Kmi Diagnostics, Inc. | Nov 24, 1997 | SESE |
| K973743 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | Oct 31, 1997 | SESE |
| K970386 | ACS ESTADIOL-6 II | Chiron Diagnostics Corp. | Jun 4, 1997 | SESE |
| K970643 | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | Johnson & Johnson Clinical Diagnostics, Inc. | Mar 18, 1997 | SESE |
| K970126 | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) | Bio-Rad Laboratories, Inc. | Feb 25, 1997 | SESE |
| K965109 | ELECSYS ESTRADIOL ASSAY | Boehringer Mannheim Corp. | Feb 18, 1997 | SESE |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Biomerieux Vitek, Inc. | Feb 6, 1996 | SESE |
| K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY | Ciba Corning Diagnostics Corp. | Dec 13, 1995 | SESE |
| K953605 | ULTRA-SENSITIVE ESTRADIOL | Diagnostic Systems Laboratories, Inc. | Oct 2, 1995 | SESE |
| K951360 | ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | Bayer Corp. | May 2, 1995 | SESE |
| K946199 | AURAFLEX(R) ESTRADIOL | Organon Teknika Corp. | Apr 3, 1995 | SESE |
| K943193 | COAT-A-COUNT(R) ESTRADIOL-6 | Diagnostic Products Corp. | Feb 23, 1995 | SESE |
| K941168 | CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT | Incstar Corp. | Sep 7, 1994 | SESE |
| K932926 | IMMULITE ESTRADIOL | Diagnostic Products Corp. | Jan 10, 1994 | SESE |
| K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Dec 3, 1993 | SESE |
| K932084 | AIA-PACK E2 ASSAY | Tosoh Medics, Inc. | Nov 9, 1993 | SESE |
| K933464 | STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | Oct 22, 1993 | SESE |
| K933066 | OPUS ESTRADIOL | Pb Diagnostic Systems, Inc. | Sep 8, 1993 | SESE |
| K931740 | COTUBE ESTRADIOL RADIOIMMUNOASSAY | Bio-Rad | Aug 16, 1993 | SESE |
Top Applicants
- Diagnostic Products Corp. — 5 clearances
- Serono-Baker Diagnostics, Inc. — 4 clearances
- Diagnostic Systems Laboratories, Inc. — 3 clearances
- Amersham Corp. — 2 clearances
- Biomerieux Vitek, Inc. — 2 clearances
