The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Modified Seralyzer Alt/sgpt Reag. Strips & Module.
| Device ID | K875079 |
| 510k Number | K875079 |
| Device Name: | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| 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 | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-04-05 |