510(k) K173704 ยท OYL Tryptase Assay System
ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Mar 2, 2018 |
| Received | Dec 4, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173704
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.