The following data is part of a premarket notification filed by Ciba Corning Diagnostics Corp. with the FDA for Kit- Ciba Corning L-tdm I, Ii, Iii.
| Device ID | K893682 |
| 510k Number | K893682 |
| Device Name: | KIT- CIBA CORNING L-TDM I, II, III |
| Classification | Drug Mixture Control Materials |
| Applicant | CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Contact | Ronald Schaefer |
| Correspondent | Ronald Schaefer CIBA CORNING DIAGNOSTICS CORP. 333 CONEY ST. E. Walpole, MA 02032 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-16 |
| Decision Date | 1989-09-28 |