FDA 510(k) Application Details - K023297

Device Classification Name	Blood, Occult, Colorimetric, In Urine   More FDA Info for this Device
510(K) Number	K023297
Device Name	Blood, Occult, Colorimetric, In Urine
Applicant	TECO DIAGNOSTICS 1268 . LAKEVIEW AVE. ANAHEIM, CA 92807 US Other 510(k) Applications for this Company
Contact	LISA TO Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	JIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/02/2002
Decision Date	03/06/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review