510(k) K951058 ยท CFR Hexokinase, Glucose
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, Jun 1, 1995 |
| Received | Mar 7, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951058
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.