510(k) K140827 ยท LCP Assay, Glycosylated Hemoglobin
SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
| Applicant | Sd Biosensor, Inc., Suwon-Si, KR |
| Decision | Substantially Equivalent, Sep 30, 2015 |
| Received | Apr 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140827
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.