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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Parathyroid Hormone
510(k) Number K031534
Device Name CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
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 Number862.1545
Classification Product Code
CEW  
Date Received05/16/2003
Decision Date 07/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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