510(k) K913133 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
| Applicant | Bionostics, Inc., Acton MA, US |
| Decision | Substantially Equivalent, Sep 27, 1991 |
| Received | Jul 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913133
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.