510(k) K051218 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
MODIFICATION TO: UNICAP SPECIFIC IGE
| Applicant | Pharmacia Diagnostics AB, Portage MI, US |
| Decision | Substantially Equivalent, Jun 9, 2005 |
| Received | May 12, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2019 | Phadia Ab Phadia" 1000
Model # 12-3800-01
Product Usage:
The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all st Terminated |
DHB | None listed |
| Dec 18, 2017 | Phadia US Inc ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01).
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be Terminated |
DHB | None listed |
| Dec 18, 2017 | Phadia US Inc ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016).
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma; to b Terminated |
DHB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.