510(k) K974261 ยท LJK Antisera, If, Toxoplasma Gondii
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
| Applicant | Boston Biomedica, Inc., West Bridgewater MA, US |
| Decision | Substantially Equivalent, Dec 11, 1997 |
| Received | Nov 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974261
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.