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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ferritin, Antigen, Antiserum, Control
510(k) Number K052617
Device Name FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,
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 Number866.5340
Classification Product Code
DBF  
Subsequent Product Codes
JIT   JJX  
Date Received09/23/2005
Decision Date 02/23/2006
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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