FDA 510(k) Application Details - K050576

Device Classification Name Albumin, Fitc, Antigen, Antiserum, Control

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510(K) Number K050576
Device Name Albumin, Fitc, 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 866.5040

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Classification Product Code DDZ
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Date Received 03/07/2005
Decision Date 04/21/2005
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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