FDA 510(k) Application Details - K012820

Device Classification Name	Immunoassay Method, Troponin Subunit   More FDA Info for this Device
510(K) Number	K012820
Device Name	Immunoassay Method, Troponin Subunit
Applicant	TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	LOIS NAKAYAMA Other 510(k) Applications for this Contact
Regulation Number	862.1215   More FDA Info for this Regulation Number
Classification Product Code	MMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2001
Decision Date	12/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review