510(k) K122197 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Aug 28, 2013 |
| Received | Jul 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2015 | Phadia US Inc Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.