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FDA 510(k)

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA

K-Number: K920981 · 1992-04-17

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1992-04-17
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1992-04-17 under 510(k) number K920981. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA?

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA is a medical device that received FDA 510(k) clearance on 1992-04-17. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K920981.

When did RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA receive FDA 510(k) clearance?

RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA received FDA 510(k) clearance on 1992-04-17, under 510(k) number K920981.

Who is the listed applicant for RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA?

The FDA 510(k) record lists Medical Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA?

The FDA product code for RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA is GGP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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