FDA 510(k) Applications for Medical Device Product Code "CHP"
(Radioimmunoassay, Estradiol)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973743 | BECKMAN INSTRUMENTS, INC. | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | 10/31/1997 |
| K970126 | BIO-RAD LABORATORIES, INC. | ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) | 02/25/1997 |
| K955647 | BIOMERIEUX VITEK, INC. | VIDAS ESTRADIOL II (E2II) ASSAY | 02/06/1996 |
| K965109 | BOEHRINGER MANNHEIM CORP. | ELECSYS ESTRADIOL ASSAY | 02/18/1997 |
| K970386 | CHIRON DIAGNOSTICS CORP. | ACS ESTADIOL-6 II | 06/04/1997 |
| K041349 | IBL GMBH | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | 09/24/2004 |
| K970643 | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. | VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050) | 03/18/1997 |
| K973901 | KMI DIAGNOSTICS, INC. | 17 B-ESTRADIOL (ELISA) | 11/24/1997 |
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