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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K861919
Device Name VENTREX APO B
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 Number862.1475
Classification Product Code
MSJ  
Date Received05/19/1986
Decision Date 06/06/1986
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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