510(k) K160113 ยท JIT Calibrator, Secondary
ST AIA-PACK hsE2 Calibrator Set
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Feb 17, 2016 |
| Received | Jan 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160113
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.