510(k) K031135 ยท CFR Hexokinase, Glucose
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jun 2, 2003 |
| Received | Apr 9, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031135
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.