The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Sera-pak Total Protein Reagent.
| Device ID | K802742 |
| 510k Number | K802742 |
| Device Name: | SERA-PAK TOTAL PROTEIN REAGENT |
| Classification | Products, Red-cell Lysing Products |
| Applicant | MILES LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-03 |
| Decision Date | 1980-12-11 |