The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Ames Tda Gentamicin Test.
| Device ID | K821669 |
| 510k Number | K821669 |
| Device Name: | AMES TDA GENTAMICIN TEST |
| Classification | Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DJB |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-07 |
| Decision Date | 1982-12-15 |