510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN200067Unknown

INNOVANCE VWF Ac

Siemens Healthcare Diagnostics Products Limited, Marburg, DE / Direct, Unknown
FDA source (opens on fda.gov)

DEN200067 is the FDA 510(k) clearance record for INNOVANCE VWF Ac, a class II device, cleared for Siemens Healthcare Diagnostics Products GmbH on under FDA product code QTY (Von Willebrand Factor Assay). FDA's definition for product code QTY reads: "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". FDA records list 23 510(k) clearances for Siemens Healthcare Diagnostics Products GmbH, from to . As of , FDA records show no recalls naming DEN200067.

Clearance record

Decision date
Received
(701 days to decision)
Product code
QTY Von Willebrand Factor Assay
Regulation
21 CFR 864.7293
Device class
Class II
Review panel
Hematology
Applicant
Siemens Healthcare Diagnostics Products GmbH Emil-Von-Behring Strasse 76, Marburg, DE
Third party review
No

Clearances, product code QTY

Trailing 12 months

FDA records hold no clearances under product code QTY in the trailing twelve months.

FDA records show no clearances under product code QTY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260