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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K091052
Device Name PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM
Applicant
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Applicant Contact Dennis M Bleile
Correspondent
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Correspondent Contact Dennis M Bleile
Regulation Number866.5270
Classification Product Code
DCN  
Date Received04/13/2009
Decision Date 01/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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