510(k) K103364 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL
| Applicant | Diamond Diagnostics, Inc., Holliston MA, US |
| Decision | Substantially Equivalent, May 6, 2011 |
| Received | Nov 16, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103364
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.