FDA 510(k) Application Details - K042641

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K042641
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	CENOGENICS CORP. 100 RT. 520 MORGANVILLE, NJ 07751 US Other 510(k) Applications for this Company
Contact	NITZA KATZ 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	09/27/2004
Decision Date	01/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review