510(k) K874809 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
| Applicant | Biotrol, USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jan 7, 1988 |
| Received | Nov 20, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K874809
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.