510(k) K070522 ยท MJH Legionella, Spp., Elisa
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012
| Applicant | Inverness Medical Professional Diagnostics, Scarborough ME, US |
| Decision | Substantially Equivalent, Mar 15, 2007 |
| Received | Feb 23, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070522
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.