510(k) K971754 ยท CFR Hexokinase, Glucose
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Jul 22, 1997 |
| Received | May 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971754
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2009 | Pointe Scientific, Inc. Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and Terminated |
CFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.