FDA 510(k) Application Details - K022725

Device Classification Name	Single (Specified) Analyte Controls (Assayed And Unassayed)   More FDA Info for this Device
510(K) Number	K022725
Device Name	Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant	GOOD BIOTECH CORP. 38, 34TH RD. TAICHUNG INDUSTRIAL PARK TAICHUNG 407 TW Other 510(k) Applications for this Company
Contact	VICTOR CHIOU Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2002
Decision Date	09/23/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review