510(k) K884544 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
DADE FACTOR VIII CHROMOGENIC ASSAY
| Applicant | Baxter Healthcare Corp, Miami FL, US |
| Decision | Substantially Equivalent, Dec 30, 1988 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884544
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2015 | Siemens Healthcare Diagnostics, Inc. Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency Terminated |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.