The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Ciba Corning Magic Lite Vitamin B12 Immunoassay.
| Device ID | K883722 |
| 510k Number | K883722 |
| Device Name: | CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY |
| Classification | Radioassay, Vitamin B12 |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | J Pignato |
| Correspondent | 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 | 1988-08-31 |
| Decision Date | 1988-11-04 |