The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Ast(sgot) In Vitro Diag. Reagent Set.
| Device ID | K813405 |
| 510k Number | K813405 |
| Device Name: | AST(SGOT) IN VITRO DIAG. REAGENT SET |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| Applicant | POINTE SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-07 |
| Decision Date | 1981-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727012555 | K813405 | 000 |