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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Aldosterone
510(k) Number K862204
Device Name RSL (125I) ALDOSTERONE KIT
Applicant
Radioassay Systems Laboratories, Inc.
2015 University Dr.
Carson,  CA  90746
Applicant Contact BURNS, PH.D
Correspondent
Radioassay Systems Laboratories, Inc.
2015 University Dr.
Carson,  CA  90746
Correspondent Contact BURNS, PH.D
Regulation Number862.1045
Classification Product Code
CJM  
Date Received06/10/1986
Decision Date 09/25/1986
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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