510(k) K161899 ยท DGC Ige, Antigen, Antiserum, Control
ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Jul 11, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161899
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2017 | Phadia US Inc Phadia 1000 Instrument, Article Number 12-3800-01. Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.