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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Acth
510(k) Number K021032
Device Name ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
Applicant
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Applicant Contact RICHARD LENART
Correspondent
Scantibodies Laboratory, Inc.
9336 Abraham Way
Santee,  CA  92071
Correspondent Contact RICHARD LENART
Regulation Number862.1025
Classification Product Code
CKG  
Date Received03/29/2002
Decision Date 06/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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