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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Human Growth Hormone
510(k) Number K971353
Device Name DSL ACTIVE NON-EXTRACTION IGF-I ELISA
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 Number862.1370
Classification Product Code
CFL  
Date Received04/11/1997
Decision Date 05/12/1997
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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