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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 K935014
Device Name ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)
Applicant
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact GOPAL SAVJANI
Correspondent
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact GOPAL SAVJANI
Regulation Number862.1245
Classification Product Code
JKC  
Date Received10/20/1993
Decision Date 05/09/1994
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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