FDA 510(k) Application Details - K982209

Device Classification Name	Test, Thrombin Time   More FDA Info for this Device
510(K) Number	K982209
Device Name	Test, Thrombin Time
Applicant	SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. ST. LOUIS, MO 63103 US Other 510(k) Applications for this Company
Contact	WILLIAN R GILBERT Other 510(k) Applications for this Contact
Regulation Number	864.7875   More FDA Info for this Regulation Number
Classification Product Code	GJA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/23/1998
Decision Date	10/15/1998
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