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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 K872879
Device Name DHEA-S RIA KIT
Applicant
Endocrine Associates, Inc.
P.O. Box 891043
Houston,  TX  77289
Applicant Contact DILIP PATEL
Correspondent
Endocrine Associates, Inc.
P.O. Box 891043
Houston,  TX  77289
Correspondent Contact DILIP PATEL
Regulation Number862.1245
Classification Product Code
JKC  
Date Received07/21/1987
Decision Date 10/23/1987
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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