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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 K051141
Device Name WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
Applicant
SCANTIBODIES LABORATORY, INC.
9336 ABRAHAM WAY
SANTEE,  CA  92071
Applicant Contact MICHAEL NORDSTROM
Correspondent
SCANTIBODIES LABORATORY, INC.
9336 ABRAHAM WAY
SANTEE,  CA  92071
Correspondent Contact MICHAEL NORDSTROM
Regulation Number862.1545
Classification Product Code
CEW  
Date Received05/04/2005
Decision Date 07/26/2005
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
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