510(k) K153712 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
| Applicant | Radiometer America, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 28, 2016 |
| Received | Dec 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153712
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.