Orthokrome* Protein C

Q: What is the product code of K900398?

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) K900398 · Ortho Diagnostic Systems, Inc.

Substantially Equivalent

510(k) numberK900398

Submission

Device name: Orthokrome* Protein C
Applicant: Ortho Diagnostic Systems, Inc.
Raritan, NJ, US
Received: January 29, 1990
Decision date: March 15, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

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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K193204	Cryocheck Chromogenic Factor VIIIGGP · Traditional	Precision Biologic	07/17/2020SE
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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 Orthokrome* Protein C cleared by the FDA?

Orthokrome* Protein C (K900398) received a 510(k) decision of Substantially Equivalent on March 15, 1990, 45 days after the submission was received.

What is the product code of K900398?

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