vWF Ag
FDA 510(k) K220728 · Siemens Healthcare Diagnostics Products GmbH
510(k) numberK220728
Submission
- Device name
- vWF Ag
- Applicant
- Siemens Healthcare Diagnostics Products GmbH
Marburg, DE - Received
- March 14, 2022
- Decision date
- June 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was vWF Ag cleared by the FDA?
vWF Ag (K220728) received a 510(k) decision of Substantially Equivalent on June 2, 2023, 445 days after the submission was received.
What is the product code of K220728?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.