The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Test For Ketone In Urine(acetoacetic Ac.
| Device ID | K801270 |
| 510k Number | K801270 |
| Device Name: | TEST FOR KETONE IN URINE(ACETOACETIC AC |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-28 |
| Decision Date | 1980-07-08 |