510(k) K041148 ยท MSQ Test, Urea (Breath Or Blood)
POCONE INFRARED SPECTROPHOTOMETER
| Applicant | Otsuka Pharmaceutical Co., Ltd., North Attleboro MA, US |
| Decision | Substantially Equivalent, Jul 15, 2004 |
| Received | May 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041148
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.