510(k) K973523 ยท LYR Helicobacter Pylori
ACCUSTAT H. PYLORI ONE STEP TEST
| Applicant | Boehringer Mannheim Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 3, 1998 |
| Received | Sep 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973523
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.