FDA 510(k) Application Details - K963111

Device Classification Name	Test, Time, Partial Thromboplastin   More FDA Info for this Device
510(K) Number	K963111
Device Name	Test, Time, Partial Thromboplastin
Applicant	CHROMOGENIX AB P.O. BOX 262069 SAN DIEGO, CA 92196-2069 US Other 510(k) Applications for this Company
Contact	RONALD G LEONARDI Other 510(k) Applications for this Contact
Regulation Number	864.7925   More FDA Info for this Regulation Number
Classification Product Code	GGW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/12/1996
Decision Date	12/23/1996
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