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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Estradiol
510(k) Number K870405
Device Name DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Applicant Contact GOPAL SAVJAMI
Correspondent
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Correspondent Contact GOPAL SAVJAMI
Regulation Number862.1260
Classification Product Code
CHP  
Date Received02/03/1987
Decision Date 06/08/1987
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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