The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Carbamazepine Test.
| Device ID | K811952 |
| 510k Number | K811952 |
| Device Name: | AMES TDA CARBAMAZEPINE TEST |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-07 |
| Decision Date | 1981-07-15 |