The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Fsh Immunoassay.
| Device ID | K904649 |
| 510k Number | K904649 |
| Device Name: | CIBA CORNING ACS FSH IMMUNOASSAY |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William J Pignato |
| Correspondent | William J Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1990-11-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414294179 | K904649 | 000 |
| 00630414599069 | K904649 | 000 |
| 00630414599052 | K904649 | 000 |
| 00630414599045 | K904649 | 000 |
| 00630414204666 | K904649 | 000 |
| 00630414177250 | K904649 | 000 |
| 00630414177243 | K904649 | 000 |
| 00630414126210 | K904649 | 000 |