HemosIL Liquid Anti-Xa— 510(k) K213464
Substantially EquivalentInstrumentation Laboratory CO
FDA 510(k) clearance K213464 for HemosIL Liquid Anti-Xa, Substantially Equivalent on 2022-10-04. Applicant: Instrumentation Laboratory CO. Device class: 2.
Clearance details
- Applicant
- Instrumentation Laboratory CO
- Product code
- Code KFF
- Device class
- Class 2
- Regulation
- 21 CFR 864.7525
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Bedford, MA, US
Recent devices under product code KFF
view all- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
- K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
- K013305 — ENOXAPARIN TEST CARD
More clearances from Instrumentation Laboratory CO
view allRecalls naming K213464
K-number listed on FDA's recall record- Z-2323-2025 — HemosIL LMW Heparin Controls; Part Number: 0020300200;
- Z-1020-2025 — HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213464.
Data sourced from openFDA. This site is unofficial and independent of the FDA.