FDA 510(k) Application Details - K972743

Device Classification Name	Alkaline Picrate, Colorimetry, Creatinine   More FDA Info for this Device
510(K) Number	K972743
Device Name	Alkaline Picrate, Colorimetry, Creatinine
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT 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	07/23/1997
Decision Date	09/22/1997
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