510(k) K151029 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
Phadia Prime
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jan 19, 2016 |
| Received | Apr 17, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151029
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2017 | Phadia Ab Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.