510(k) K101633 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Jun 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101633
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.