The following data is part of a premarket notification filed by Vitek Systems, Inc. with the FDA for Procainamide Calibrator Kit.
| Device ID | K780732 |
| 510k Number | K780732 |
| Device Name: | PROCAINAMIDE CALIBRATOR KIT |
| Classification | Calibrators, Drug Specific |
| Applicant | VITEK SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-02 |
| Decision Date | 1978-11-22 |