FDA 510(k) Application Details - K050801

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K050801
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	YD DIAGNOSTICS 707 FOOTHILL BLVD. STE. 200 LA CANADA, CA 91011 US Other 510(k) Applications for this Company
Contact	JERRI HOI Other 510(k) Applications for this Contact
Regulation Number	862.1340   More FDA Info for this Regulation Number
Classification Product Code	JIL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/30/2005
Decision Date	04/20/2005
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