510(k) K911496 ยท LSR Reagent, Borrelia Serological Reagent
FASTTECH SYSTEM 1
| Applicant | 3M Diagnostic Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 24, 1991 |
| Received | Apr 4, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911496
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.