510(k) K943811 ยท CFT Radioimmunoassay, Prolactin (Lactogen)
ENZYME-LINKED FLUORESCENT IMMUNOASSAY
| Applicant | Biomerieux Vitek, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Nov 2, 1994 |
| Received | Aug 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943811
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.