510(k) K011900 ยท CFR Hexokinase, Glucose
GLUCOSE (HEXOKINASE)
| Applicant | Jas Diagnostics, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Jul 31, 2001 |
| Received | Jun 18, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2014 | JAS Diagnostics Inc. Glucose Hexokinase (Liquid) Reagent
For the in vitro quantitative determination of Glucose in serum. Terminated |
CFR | None listed |
| Jun 25, 2014 | JAS Diagnostics Inc. Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. Terminated |
CGA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.