510(k) K941132 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
LIQUID AST (SGOT)REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, May 2, 1994 |
| Received | Mar 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2017 | Medtest Holdings, Inc. Pointe Scientific Hitachi AST Reagent
R1 : PE plastic bottle w/PP plastic cap.
R2: PE plastic bottle w /PP plastic cap.
Product Usage:
Two Part Chemistry Reagent For the quantitative determination o Terminated |
CIT | None listed |
| Oct 22, 2008 | Pointe Scientific, Inc. Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate Terminated |
CIT | None listed |
| Oct 22, 2008 | Pointe Scientific, Inc. AST R1 Reagent, 120 ml., Pointe Scientific, Inc., Canton, MI; Catalog no. 8-A7561-R1-120. For the quantitative determination of aspartate amoinotransferase in human serum Terminated |
CIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.