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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 K003174
Device Name ELECSYS DHEA-S
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Applicant Contact KAY A TAYLOR
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250
Correspondent Contact KAY A TAYLOR
Regulation Number862.1245
Classification Product Code
JKC  
Date Received10/10/2000
Decision Date 01/17/2001
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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