Cleared Traditional

vWF Ag

K220728 · Siemens Healthcare Diagnostics Products GmbH · Hematology
Jun 2023
Decision
445d
Days
Class 2
Risk

About This 510(k) Submission

K220728 is an FDA 510(k) clearance for the vWF Ag, a Test, Qualitative And Quantitative Factor Deficiency (Class II — Special Controls, product code GGP), submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on June 2, 2023, 445 days after receiving the submission on March 14, 2022. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K220728 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2022
Decision Date June 02, 2023
Days to Decision 445 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGP — Test, Qualitative And Quantitative Factor Deficiency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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