FDA 510(k) Application Details - K111335

Device Classification Name	Radioimmunoassay, Acth   More FDA Info for this Device
510(K) Number	K111335
Device Name	Radioimmunoassay, Acth
Applicant	Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	JUDITH K OGDEN Other 510(k) Applications for this Contact
Regulation Number	862.1025   More FDA Info for this Regulation Number
Classification Product Code	CKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2011
Decision Date	12/01/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review