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FDA 510(k)

VON WILLEBRAND FACTOR ANTIGEN SCREEN

K-Number: K842537 · 1984-10-01

ApplicantAmerican Dade
Decision Date1984-10-01
Product CodeICF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VON WILLEBRAND FACTOR ANTIGEN SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-10-01 under 510(k) number K842537. The device is classified under product code ICF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VON WILLEBRAND FACTOR ANTIGEN SCREEN?

VON WILLEBRAND FACTOR ANTIGEN SCREEN is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is American Dade. The 510(k) number is K842537.

When did VON WILLEBRAND FACTOR ANTIGEN SCREEN receive FDA 510(k) clearance?

VON WILLEBRAND FACTOR ANTIGEN SCREEN received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842537.

Who is the listed applicant for VON WILLEBRAND FACTOR ANTIGEN SCREEN?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VON WILLEBRAND FACTOR ANTIGEN SCREEN?

The FDA product code for VON WILLEBRAND FACTOR ANTIGEN SCREEN is ICF.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: ICF)

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.

K864531TISSUE GRAM STAINSigma Diagnostics, Inc.K842730GENTIAN VIOLETE K Ind., Inc.K821503IRIS URINE STAINIntl. Remote Imaging SystemsK792495VOLU-SOL URINARY SEDIMENT STAINVolu Sol Medical Industries

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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