510(k) K112315 ยท JHI Visual, Pregnancy Hcg, Prescription Use
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| Applicant | Newscen Coast Bio-Pharmaceutical Co., Ltd., Simi Valley CA, US |
| Decision | Substantially Equivalent, Apr 23, 2012 |
| Received | Aug 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112315
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.