510(k) K092817 ยท MSQ Test, Urea (Breath Or Blood)
POC-AS10 AUTO SAMPLER
| Applicant | Otsuka Pharmaceutical Co., Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Mar 9, 2010 |
| Received | Sep 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092817
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.