510(k) K012431 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Aug 28, 2001 |
| Received | Jul 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012431
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.