Ristocetin Cofactor Assay/Von Willebrand Fact Assa

Q: What is the product code of K920981?

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) K920981 · Medical Diagnostic Technologies, Inc.

Substantially Equivalent

510(k) numberK920981

Submission

Device name: Ristocetin Cofactor Assay/Von Willebrand Fact Assa
Applicant: Medical Diagnostic Technologies, Inc.
Ventura, CA, US
Received: March 2, 1992
Decision date: April 17, 1992
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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Questions and answers

When was Ristocetin Cofactor Assay/Von Willebrand Fact Assa cleared by the FDA?

Ristocetin Cofactor Assay/Von Willebrand Fact Assa (K920981) received a 510(k) decision of Substantially Equivalent on April 17, 1992, 46 days after the submission was received.

What is the product code of K920981?

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