FDA 510(k) Application Details - K022049

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K022049
Device Name	Azo Dye, Calcium
Applicant	HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. COLUMBIA, MD 21045 US Other 510(k) Applications for this Company
Contact	JOSE A MONTANEZ Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/24/2002
Decision Date	07/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review