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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 K905612
Device Name VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
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 Number866.5510
Classification Product Code
DGC  
Date Received12/14/1990
Decision Date 02/21/1991
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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