510(k) K052716 ยท LYR Helicobacter Pylori
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
| Applicant | Otsuka Pharmaceutical Co., Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Nov 16, 2006 |
| Received | Sep 29, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052716
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.