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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K823453
Device Name VON WILLEBRAND FACTOR ASSAY
Applicant
GENERAL DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL DIAGNOSTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7290
Classification Product Code
GGP  
Date Received11/17/1982
Decision Date 01/21/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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