The following data is part of a premarket notification filed by Chiron Diagnostics Corp. with the FDA for Acs Estadiol-6 Ii.
| Device ID | K970386 |
| 510k Number | K970386 |
| Device Name: | ACS ESTADIOL-6 II |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Contact | Thomas F Flynn |
| Correspondent | Thomas F Flynn CHIRON DIAGNOSTICS CORP. 63 NORTH ST. Medfield, MA 02052 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-06-04 |