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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 K004038
Device Name TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
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  
Subsequent Product Codes
JIS   JJX  
Date Received12/28/2000
Decision Date 04/30/2001
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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