The following data is part of a premarket notification filed by Tudor Laboratories, Inc. with the FDA for Primidone (fpia) Calibrator Kit.
| Device ID | K895568 |
| 510k Number | K895568 |
| Device Name: | PRIMIDONE (FPIA) CALIBRATOR KIT |
| Classification | Calibrators, Drug Specific |
| Applicant | TUDOR LABORATORIES, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1070 - LOCK BOX 45 Dallas, TX 75206 |
| Contact | Dowben, Md |
| Correspondent | Dowben, Md TUDOR LABORATORIES, INC. 5910 N. CENTRAL EXPRESSWAY SUITE 1070 - LOCK BOX 45 Dallas, TX 75206 |
| Product Code | DLJ |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-06 |
| Decision Date | 1989-09-28 |