FDA 510(k) Application Details - K970087

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K970087
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	CHIMERA RESEARCH & CHEMICAL, INC. 4309 TYSON AVENUE WEST TAMPA, FL 33681 US Other 510(k) Applications for this Company
Contact	CHARLES A HAY, PH.D. Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/1997
Decision Date	03/06/1997
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