FDA 510(k) Application Details - K153651

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K153651
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	BECKMAN COULTER, INC. Immunodiagnostic Development Center 1000 LAKE HAZELTINE DRIVE CHASKA, MN 55318-1361 US Other 510(k) Applications for this Company
Contact	MICHAEL ROBERT LORENZ Other 510(k) Applications for this Contact
Regulation Number	862.1690   More FDA Info for this Regulation Number
Classification Product Code	JLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2015
Decision Date	08/18/2016
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