FDA 510(k) Application Details - K972257

Device Classification Name	Antigen, Antiserum, Control, Antithrombin Iii   More FDA Info for this Device
510(K) Number	K972257
Device Name	Antigen, Antiserum, Control, Antithrombin Iii
Applicant	CRESTAT DIAGNOSTICS, INC. 374 GOODHILL RD. WESTON, CT 06883 US Other 510(k) Applications for this Company
Contact	MARY REES Other 510(k) Applications for this Contact
Regulation Number	864.7060   More FDA Info for this Regulation Number
Classification Product Code	DDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/1997
Decision Date	10/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review