510(k) K920668 ยท GHH Fibrin Split Products
MINUTEX D-DIMER LATEX TEST
| Applicant | Biopool AB, Ontario, L7l 6b8, CA |
| Decision | Substantially Equivalent, Oct 16, 1992 |
| Received | Feb 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2011 | Tcoag Us, Incorporated Minutex D-Dimer ; Trinity Biotech plc,
Bray,
Co. Wicklow,
Ireland.
Tel: (353) 1 276 9800,
Fax: (353) 1 276 9888,
Web: www.trinitybiotech.com
Minutex D-Dimer is a latex agglutination test for semiquan Terminated |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.