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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 K020603
Device Name CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010
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  
Date Received02/25/2002
Decision Date 06/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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