Sta-Liatest Free Protein S Test Kit

Q: What is the product code of K010963?

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) K010963 · Diagnostica Stago, Inc.

Substantially Equivalent

510(k) numberK010963

Submission

Device name: Sta-Liatest Free Protein S Test Kit
Applicant: Diagnostica Stago, Inc.
Parisppany, NJ, US
Received: March 30, 2001
Decision date: June 6, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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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K200033	HemosIL von Willebrand Factor AntigenGGP · Special	Instrumentation Laboratory CO	08/19/2020SE
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K183440	CRYOcheck FVIII Inhibitor KitGGP · Traditional	Precision Biologic, Inc.	03/12/2019SE
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 Sta-Liatest Free Protein S Test Kit cleared by the FDA?

Sta-Liatest Free Protein S Test Kit (K010963) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 68 days after the submission was received.

What is the product code of K010963?

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