STA® - Liquid Anti-Xa— 510(k) K260214
Substantially EquivalentDiagnostica Stago, Inc.
FDA 510(k) clearance K260214 for STA® - Liquid Anti-Xa, Substantially Equivalent on 2026-09-24. Applicant: Diagnostica Stago, Inc.. Device class: 2.
Summary
STA Liquid Anti-Xa from Diagnostica Stago, Inc. is a heparin assay, filed under KFF. The record doesn't say which heparins or calibrators this version covers.
Class II, 21 CFR 864.7525, Hematology panel. Stago filed it as a Special 510(k).
Stago filed from Parsippany, New Jersey. Review took 244 days (January 23 to September 24, 2026). The record doesn't explain the length of the clock.
Clearance details
- Applicant
- Diagnostica Stago, Inc.
- Product code
- Product 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
- Parsippany, NJ, US
Recent devices under product code KFF
view all- K213464 — HemosIL Liquid Anti-Xa
- 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
More clearances from Diagnostica Stago, Inc.
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