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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Fitc, Antigen, Antiserum, Control
510(k) Number K050576
Device Name MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-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 Number866.5040
Classification Product Code
DDZ  
Subsequent Product Codes
JIT   JJX  
Date Received03/07/2005
Decision Date 04/21/2005
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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