The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Primidone Test.
| Device ID | K802654 |
| 510k Number | K802654 |
| Device Name: | AMES TDA PRIMIDONE TEST |
| Classification | Enzyme Immunoassay, Primidone |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DJD |
| CFR Regulation Number | 862.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-24 |
| Decision Date | 1980-11-12 |