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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ige, antigen, antiserum, control
510(k) Number K822442
Device Name VAST VENTREX RAST ALLERGEN DISCS
Applicant
VENTREX LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VENTREX LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5510
Classification Product Code
DGC  
Date Received08/16/1982
Decision Date 09/02/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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