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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
510(k) Number K823200
Device Name 125 I-DEHYDROEPIANDROSTERONE SULFATE
Applicant
Wien Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Wien Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1245
Classification Product Code
JKC  
Date Received10/26/1982
Decision Date 11/29/1982
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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