510(k) K960183 ยท LYR Helicobacter Pylori
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
| Applicant | Smithkline Diagnostics, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 7, 1996 |
| Received | Jan 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960183
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.