FDA 510(k) Application Details - K003012

Device Classification Name	Phosphomolybdate (Colorimetric), Inorganic Phosphorus   More FDA Info for this Device
510(K) Number	K003012
Device Name	Phosphomolybdate (Colorimetric), Inorganic Phosphorus
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	862.1580   More FDA Info for this Regulation Number
Classification Product Code	CEO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2000
Decision Date	10/25/2000
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