510(k) K133404 ยท DGC Ige, Antigen, Antiserum, Control
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
| Applicant | Phadia AB, Portage MI, US |
| Decision | Substantially Equivalent, Feb 24, 2014 |
| Received | Nov 6, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133404
| 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 |
| 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.