FDA 510(k) Application Details - K233060

Device Classification Name	Acid, Folic, Radioimmunoassay   More FDA Info for this Device
510(K) Number	K233060
Device Name	Acid, Folic, Radioimmunoassay
Applicant	Roche Diagnostics 9115 Hague Rd. Building B Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Amy Pierce Other 510(k) Applications for this Contact
Regulation Number	862.1295   More FDA Info for this Regulation Number
Classification Product Code	CGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2023
Decision Date	06/17/2024
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