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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 K063605
Device Name ST AIA-PACK INTACT PTH ASSAY
Applicant
Tosoh BioScience, Inc.
3600 GANTZ ROAD
GROVE CITY,  OH  43123
Applicant Contact CHARLES P GILL
Correspondent
Tosoh BioScience, Inc.
3600 GANTZ ROAD
GROVE CITY,  OH  43123
Correspondent Contact CHARLES P GILL
Regulation Number862.1545
Classification Product Code
CEW  
Subsequent Product Codes
JIT   JJX  
Date Received12/04/2006
Decision Date 06/21/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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