510(k) K170652 ยท PRI Procalcitonin Assay
ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
| Applicant | Fisher Diagnostics, Middletown VA, US |
| Decision | Substantially Equivalent, Jun 1, 2017 |
| Received | Mar 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170652
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.