The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Liquid Ast (sgot)reagent Set.
| Device ID | K941132 |
| 510k Number | K941132 |
| Device Name: | LIQUID AST (SGOT)REAGENT SET |
| Classification | Nadh Oxidation/nad Reduction, Ast/sgot |
| 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 | CIT |
| CFR Regulation Number | 862.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-09 |
| Decision Date | 1994-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014924 | K941132 | 000 |
| 00811727016041 | K941132 | 000 |
| 00817439020222 | K941132 | 000 |
| 00817439020239 | K941132 | 000 |
| 00817439020246 | K941132 | 000 |
| 00811727010377 | K941132 | 000 |
| 00811727010384 | K941132 | 000 |
| 00811727010391 | K941132 | 000 |
| 00811727012890 | K941132 | 000 |
| 00811727013415 | K941132 | 000 |
| 00811727013798 | K941132 | 000 |
| 00811727013804 | K941132 | 000 |
| 00811727013811 | K941132 | 000 |
| 00811727013828 | K941132 | 000 |
| 00811727014610 | K941132 | 000 |
| 00811727015730 | K941132 | 000 |