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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 K912850
Device Name SHBG
Applicant
Wien Laboratories, Inc.
P.O. Box 227
Succasunna,  NJ  07876
Applicant Contact BRET G WIEN
Correspondent
Wien Laboratories, Inc.
P.O. Box 227
Succasunna,  NJ  07876
Correspondent Contact BRET G WIEN
Regulation Number862.1680
Classification Product Code
CDZ  
Date Received06/28/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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