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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test,Alpha-Fetoprotein For Testicular Cancer
510(k) Number K990138
Device Name DSL ACTIVE AFP ELISA, MODEL DSL-10-8400
Applicant
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Applicant Contact JOHN CLASS
Correspondent
Diagnostic Systems Laboratories, Inc.
445 Medical Center Blvd.
Webster,  TX  77598
Correspondent Contact JOHN CLASS
Regulation Number866.6010
Classification Product Code
LOJ  
Date Received01/19/1999
Decision Date 06/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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