The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Alt(sgpt) Reagent Set.
| Device ID | K941287 |
| 510k Number | K941287 |
| Device Name: | LIQUID ALT(SGPT) REAGENT SET |
| Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | William F Walters,jr. |
| Correspondent | William F Walters,jr. POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CKA |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-17 |
| Decision Date | 1994-05-03 |