FDA 510(k) Application Details - K230161

Device Classification Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)   More FDA Info for this Device
510(K) Number	K230161
Device Name	Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)
Applicant	Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Dr. Leslie Patterson Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	MOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2023
Decision Date	03/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review