510(k) K112449 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., Yorba Linda CA, US |
| Decision | Substantially Equivalent, Sep 24, 2012 |
| Received | Aug 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112449
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.