510(k) K993388 ยท DHB System, Test, Radioallergosorbent (Rast) Immunological
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
| Applicant | Pharmacia & Upjohn Co., Westervillle OH, US |
| Decision | Substantially Equivalent, Dec 1, 1999 |
| Received | Oct 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993388
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.