510(k) K982238 ยท MJH Legionella, Spp., Elisa
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
| Applicant | Binax, Inc., Portland ME, US |
| Decision | Substantially Equivalent, Aug 21, 1998 |
| Received | Jun 25, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2006 | Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Product Code: 852-000 Terminated |
MJH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.