TRIAGE D-DIMER TEST, MODEL 98100— 510(k) K042890
Substantially EquivalentBiosite Incorporated
FDA 510(k) clearance K042890 for TRIAGE D-DIMER TEST, MODEL 98100, Substantially Equivalent on 2004-11-29. Applicant: Biosite Incorporated. Device class: 2.
Clearance details
- Applicant
- Biosite Incorporated
- Product code
- Code GHH
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Biosite Incorporated
view allRecalls naming K042890
K-number listed on FDA's recall record- Z-1727-2014 — 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 fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
- Z-1932-2012 — 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042890.
Data sourced from openFDA. This site is unofficial and independent of the FDA.