Shield Von Willebrand Factor Activity Elisa, Model FVWF 200

Q: What is the product code of K000398?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.

FDA 510(k) K000398 · Shield Diagnostics, Ltd.

Substantially Equivalent

510(k) numberK000398

Submission

Device name: Shield Von Willebrand Factor Activity Elisa, Model FVWF 200
Applicant: Shield Diagnostics, Ltd.
Dundee, GB
Received: February 7, 2000
Decision date: April 17, 2000
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

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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K181525	INNOVANCE Free PS AgGGP · Traditional	Siemens Healthcare Diagnostics Products GmbH	09/07/2018SE
K133005	Hemosil Von Willebrand Activity AssayGGP · Special	Instrumentation Laboratory CO	03/13/2014SE

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Questions and answers

When was Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 cleared by the FDA?

Shield Von Willebrand Factor Activity Elisa, Model FVWF 200 (K000398) received a 510(k) decision of Substantially Equivalent on April 17, 2000, 70 days after the submission was received.

What is the product code of K000398?

The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.