The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Prolactin Immunoassay.
| Device ID | K904714 |
| 510k Number | K904714 |
| Device Name: | CIBA CORNING ACS PROLACTIN IMMUNOASSAY |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | J Pignato |
| Correspondent | J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-18 |
| Decision Date | 1990-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414204604 | K904714 | 000 |
| 00630414177274 | K904714 | 000 |
| 00630414177267 | K904714 | 000 |