FDA 510(k) Application Details - K010158

Device Classification Name	Reagent, Thromboplastin And Control   More FDA Info for this Device
510(K) Number	K010158
Device Name	Reagent, Thromboplastin And Control
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAM R GILBERT II Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GGO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2001
Decision Date	03/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review