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FDA 510(k) Application Details - K052617
Device Classification Name
Ferritin, Antigen, Antiserum, Control
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510(K) Number
K052617
Device Name
Ferritin, Antigen, Antiserum, Control
Applicant
GOOD BIOTECH CORP.
38, 34TH RD.
TAICHUNG INDUSTRIAL PARK
TAICHUNG 407 TW
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Contact
VICTOR CHIOU
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Regulation Number
866.5340
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Classification Product Code
DBF
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More FDA Info for this Product Code
Date Received
09/23/2005
Decision Date
02/23/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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