510(k) K864006 ยท LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST
| Applicant | Medical Diagnostic Technologies, Inc., Augusta GA, US |
| Decision | Substantially Equivalent, Apr 20, 1987 |
| Received | Oct 15, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864006
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.