510(k) K870089 ยท GTJ Antisera, All Groups, N. Meningitidis
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT
| Applicant | Microscan Div. Baxter Healthcare Corp., West Sacramento CA, US |
| Decision | Substantially Equivalent, Mar 17, 1987 |
| Received | Jan 9, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870089
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.