510(k) K032453 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
| Applicant | Bionostics, Inc., Devens MA, US |
| Decision | Substantially Equivalent, Aug 28, 2003 |
| Received | Aug 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032453
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.