510(k) K031101 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
| Applicant | Hemagen Diagnostics, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Jun 16, 2003 |
| Received | Apr 7, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031101
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.