510(k) K963318 ยท LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
| Applicant | Armkel, LLC, Frederick MD, US |
| Decision | Substantially Equivalent, Mar 3, 1997 |
| Received | Aug 23, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963318
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.