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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 K951707
Device Name DSL ACTIVE IFGBP-3 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 Received04/13/1995
Decision Date 05/10/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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