STA® - Liatest® D-Di— 510(k) K162227
Substantially EquivalentDiagnostica Stago
FDA 510(k) clearance K162227 for STA® - Liatest® D-Di, Substantially Equivalent on 2016-12-10. Applicant: Diagnostica Stago. Device class: 2.
Clearance details
- Applicant
- Diagnostica Stago
- Product code
- Code DAP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7320
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Asnieres Sur Seine, FR
Recent devices under product code DAP
view allMore clearances from Diagnostica Stago
view allRecalls naming K162227
K-number listed on FDA's recall record- Z-1585-2026 — Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No
- Z-0205-2026 — Product: STA Liatest D-Di; REF: 00515;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162227.
Data sourced from openFDA. This site is unofficial and independent of the FDA.