510(k) K010864 ยท KHS Enzymatic, Carbon-Dioxide
ANALYST PANELS + ANALYTICAL TEST ROTOR
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Mar 22, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010864
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.