The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Theophylline Control Serum.
| Device ID | K780961 |
| 510k Number | K780961 |
| Device Name: | THEOPHYLLINE CONTROL SERUM |
| Classification | Drug Specific Control Materials |
| Applicant | VITEK SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-12 |
| Decision Date | 1978-12-07 |