The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Acs T3 Immunoassay.
| Device ID | K913646 |
| 510k Number | K913646 |
| Device Name: | CIBA CORNING ACS T3 IMMUNOASSAY |
| Classification | Radioassay, Vitamin B12 |
| 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 | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-16 |
| Decision Date | 1991-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414599960 | K913646 | 000 |
| 00630414599953 | K913646 | 000 |
| 00630414175386 | K913646 | 000 |
| 00630414175379 | K913646 | 000 |