510(k) K061047 ยท GKR System, Hemoglobin, Automated
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
| Applicant | Hemocue AB, Lake Forest CA, US |
| Decision | Substantially Equivalent, Jun 8, 2006 |
| Received | Apr 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061047
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.