Mda Protein Assay

Q: When was Mda Protein Assay cleared by the FDA?

Mda Protein Assay (K925617) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 447 days after the submission was received.

Q: What is the product code of K925617?

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) K925617 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK925617

Submission

Device name: Mda Protein Assay
Applicant: Organon Teknika Corp.
Durham, NC, US
Received: November 6, 1992
Decision date: January 27, 1994
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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K214002	CRYOcheck Chromogenic Factor IXGGP · Traditional	Precision Biologic, Inc.	12/23/2022SE
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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 Mda Protein Assay cleared by the FDA?

Mda Protein Assay (K925617) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 447 days after the submission was received.

What is the product code of K925617?

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