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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 K060348
Device Name MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
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 Received02/10/2006
Decision Date 02/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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