510(k) K131928 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
FREND TSH (REAGENT CARTRIDGE)
| Applicant | Nanoentek USA, Inc., Oxford CT, US |
| Decision | Substantially Equivalent, Mar 14, 2014 |
| Received | Jun 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131928
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.