The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs T4 Immunoassay.
| Device ID | K905532 |
| 510k Number | K905532 |
| Device Name: | CIBA CORNING ACS T4 IMMUNOASSAY |
| Classification | Radioimmunoassay, Total Thyroxine |
| 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 | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-10 |
| Decision Date | 1991-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599991 | K905532 | 000 |
| 00630414177052 | K905532 | 000 |
| 00630414177045 | K905532 | 000 |
| 00630414125121 | K905532 | 000 |