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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K851403
Device Name VENTREZYME ALLERGEN DATA REDUCTION SYSTEM
Applicant
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Applicant Contact JAMES W CHAMPLIN
Correspondent
Ventrex Laboratories, Inc.
217 Read St.
P.O. Box 9731
Portland,  ME  04103
Correspondent Contact JAMES W CHAMPLIN
Regulation Number862.2750
Classification Product Code
JQW  
Date Received04/09/1985
Decision Date 06/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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