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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K041155
Device Name WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
Applicant
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Applicant Contact ADAOBI OGUCHI
Correspondent
Stanbio Laboratory
1261 N. Main St.
Boerne,  TX  78006
Correspondent Contact ADAOBI OGUCHI
Regulation Number866.5270
Classification Product Code
DCK  
Subsequent Product Codes
JIT   JIX  
Date Received05/03/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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