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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Androstenedione
510(k) Number K963002
Device Name ACTIVE ANDROSTENEDIONE EIA
Applicant
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact JOHN WILLIS
Correspondent
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact JOHN WILLIS
Regulation Number862.1075
Classification Product Code
CIZ  
Date Received08/02/1996
Decision Date 08/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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