The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Theophylline(theo).
| Device ID | K933258 |
| 510k Number | K933258 |
| Device Name: | VIDAS THEOPHYLLINE(THEO) |
| Classification | Enzyme Immunoassay, Theophylline |
| Applicant | BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Contact | Vieki Anastasi |
| Correspondent | Vieki Anastasi BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland, MA 02370 |
| Product Code | KLS |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-06 |
| Decision Date | 1993-08-16 |