510(k) K941287 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
LIQUID ALT(SGPT) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, May 3, 1994 |
| Received | Mar 17, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941287
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 150 ml, Catalog no. A7526-150, in vitro diagnostic, Pointe Scientific, Inc.; Ca Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Ca Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 625 ml, Catalog no. A7526-625, in vitro diagnostic, Pointe Scientific, Inc.; Ca Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 504 ml, Catalog no. HA926-504, in vitro diagnostic, Pointe Scientific, Inc.; Ca Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 610 ml, Catalog no. HA926-610, in vitro diagnostic, Pointe Scientific, Inc.; Ca Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 7-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 120 ml, Catalog no. 8-A7526-R1-120, in vitro diagnostic, Pointe Scientific, Inc Terminated |
CKA | None listed |
| May 22, 2008 | Pointe Scientific, Inc. Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 305 ml, Catalog no. HA 726-305, in vitro diagnostic, Pointe Scientific, Inc.; C Terminated |
CKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.