510(k) K972048 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
ACCURUN 117 HBEAG POSITIVE CONTROL
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Aug 12, 1997 |
| Received | Jun 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972048
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.