The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Acs Digoxin Immunoassay.
| Device ID | K931213 |
| 510k Number | K931213 |
| Device Name: | ACS DIGOXIN IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | William Pignato |
| Correspondent | William Pignato CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-10 |
| Decision Date | 1993-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598826 | K931213 | 000 |
| 00630414598819 | K931213 | 000 |
| 00630414177427 | K931213 | 000 |
| 00630414177410 | K931213 | 000 |