510(k) K162378 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FREND PSA PLUS (reagent cartridge)
| Applicant | Nanoentek USA, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 17, 2017 |
| Received | Aug 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162378
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.