FDA 510(k) Application Details - K234091

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K234091
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	Genalyte, Inc. 6620 Mesa Ridge Rd San Diego, CA 92121 US Other 510(k) Applications for this Company
Contact	Sasi Mudumba 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	12/26/2023
Decision Date	07/22/2024
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