The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Serayzer Alt/sgpt Reagent Strips.
| Device ID | K832791 |
| 510k Number | K832791 |
| Device Name: | SERAYZER ALT/SGPT REAGENT STRIPS |
| Classification | Vanillin Pyruvate, Alt/sgpt |
| Applicant | MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CKC |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-19 |
| Decision Date | 1983-10-14 |