The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Optimate Digoxin Test.
| Device ID | K853021 |
| 510k Number | K853021 |
| Device Name: | OPTIMATE DIGOXIN TEST |
| Classification | Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Charcoal Sep. |
| Applicant | MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Contact | John H Engelmann |
| Correspondent | John H Engelmann MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart, IN 46514 |
| Product Code | DPB |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-18 |
| Decision Date | 1985-08-07 |