510(k) K042890 ยท GHH Fibrin Split Products
TRIAGE D-DIMER TEST, MODEL 98100
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Nov 29, 2004 |
| Received | Oct 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2014 | Alere San Diego, Inc. Alere Triage D-Dimer Test
PN 98100, Lot W53884B.
The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked Terminated |
GHH | None listed |
| Jul 6, 2012 | Alere San Diego, Inc. Triage D-dimer PN 98100
Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism. Terminated |
GHH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.