FDA 510(k) Application Details - K954968

Device Classification Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)   More FDA Info for this Device
510(K) Number	K954968
Device Name	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Applicant	TCPI, INC. 15 OAK ST. BEVERLY FARMS, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE 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	10/27/1995
Decision Date	07/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review