The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs Tsh Immunoassay.
| Device ID | K910981 |
| 510k Number | K910981 |
| Device Name: | CIBA CORNING ACS TSH IMMUNOASSAY |
| Classification | Radioimmunoassay, Thyroid-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 | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-07 |
| Decision Date | 1991-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414979458 | K910981 | 000 |
| 00630414204581 | K910981 | 000 |
| 00630414177038 | K910981 | 000 |
| 00630414177021 | K910981 | 000 |
| 00630414126258 | K910981 | 000 |