The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Plus Chem S.c.e. Reagent.
| Device ID | K791080 |
| 510k Number | K791080 |
| Device Name: | PLUS CHEM S.C.E. REAGENT |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-12 |
| Decision Date | 1979-07-24 |