The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Tmc I, Ii.
| Device ID | K930534 |
| 510k Number | K930534 |
| Device Name: | TMC I, II |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Ronald D Schaefer |
| Correspondent | Ronald D Schaefer CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1994-04-04 |