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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, testosterones and dihydrotestosterone
510(k) Number K905247
Device Name SHBG IRMA KIT
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 Number862.1680
Classification Product Code
CDZ  
Date Received11/21/1990
Decision Date 01/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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