510(k) K993276 ยท GHH Fibrin Split Products
SIMPLIFY D-DIMER, MODEL DCGK1
| Applicant | Agen Biomedical , Ltd., Brisbane, Queensland, AU |
| Decision | Substantially Equivalent, Dec 14, 1999 |
| Received | Sep 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2007 | Inverness Medical Professional Diagnostics Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole blood and plasma.
Product No. 61100KVC
10 test devices containing anti D-dimer monoclonal antibod Terminated |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.