FDA 510(k) Application Details - K994349

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K994349
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	JENNIFER TRIBBETT Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/1999
Decision Date	09/06/2000
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