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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 K050713
Device Name DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
Applicant
Good Biotech Corp.
38, 34th Rd.
Taichung Industrial Park
Taichung,  TW 407
Applicant Contact VICTOR CHIOU
Correspondent
Good Biotech Corp.
38, 34th Rd.
Taichung Industrial Park
Taichung,  TW 407
Correspondent Contact VICTOR CHIOU
Regulation Number866.5270
Classification Product Code
DCN  
Subsequent Product Code
JIT  
Date Received03/18/2005
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
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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