510(k) K971406 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ACCURUN 120 HAV IGG POSITIVE CONTROL
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Aug 7, 1997 |
| Received | Apr 16, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971406
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.