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FDA 510(k)

REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT

K-Number: K972005 · 1997-08-13

ApplicantReaads Medical Products, Inc.
Decision Date1997-08-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Reaads Medical Products, Inc.. It received FDA 510(k) clearance on 1997-08-13 under 510(k) number K972005. 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 REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT?

REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT is a medical device that received FDA 510(k) clearance on 1997-08-13. The listed applicant is Reaads Medical Products, Inc.. The 510(k) number is K972005.

When did REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT receive FDA 510(k) clearance?

REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT received FDA 510(k) clearance on 1997-08-13, under 510(k) number K972005.

Who is the listed applicant for REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT?

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

What is the FDA product code for REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT?

The FDA product code for REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT is GGP.

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Other records listing Reaads Medical Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972342REAADS PROTEIN C ANTIGEN TEST KITK972482REAADS PROTEIN S ANTIGEN TEST KITK952287REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT

Related Devices (Code: GGP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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