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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 K830817
Device Name NEW ALLERGEN DISCS FOR USE IN VAST VENT
Applicant
Ventrex Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Ventrex Laboratories, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number866.5510
Classification Product Code
DGC  
Date Received03/15/1983
Decision Date 04/27/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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