510(k) K970149 ยท LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
LEGIONELLA ELISA TEST SYSTEM
| Applicant | Zeus Scientific, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Jun 18, 1997 |
| Received | Jan 15, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2005 | Diamedix Corporation The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Terminated |
LHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.