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510(k) DEN200067

INNOVANCE VWF Ac by Siemens Healthcare Diagnostics Products GmbH — Product Code QTY

DEN200067 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics Products GmbH for the device "INNOVANCE VWF Ac". The FDA issued a decision of De Novo Granted on September 29, 2022. The device falls under product code QTY (Von Willebrand Factor Assay), a Class II device regulated under 21 CFR 864.7293. Siemens Healthcare Diagnostics Products GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 29, 2022
Date Received
October 28, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Von Willebrand Factor Assay
Device Class
Class II
Regulation Number
864.7293
Review Panel
HE
Submission Type

A von Willebrand factor assay is a prescription device intended for the measurement of von Willebrand factor activity or von Willebrand factor size distribution in human plasma.

Other clearances by Siemens Healthcare Diagnostics Products GmbH

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (January 15, 2021)

FDA data resources