FDA 510(k) Application Details - K972960

Device Classification Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K972960
Device Name	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
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	862.1645   More FDA Info for this Regulation Number
Classification Product Code	JIR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/1997
Decision Date	10/07/1998
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