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FDA 510(k) Application Details - K050713
Device Classification Name
System, Test, C-Reactive Protein
More FDA Info for this Device
510(K) Number
K050713
Device Name
System, Test, C-Reactive Protein
Applicant
GOOD BIOTECH CORP.
38, 34TH RD.
TAICHUNG INDUSTRIAL PARK
TAICHUNG 407 TW
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Contact
VICTOR CHIOU
Other 510(k) Applications for this Contact
Regulation Number
866.5270
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Classification Product Code
DCN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/2005
Decision Date
06/06/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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