FDA 510(k) Application Details - K190326

Device Classification Name	Urease, Photometric, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K190326
Device Name	Urease, Photometric, Urea Nitrogen
Applicant	Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626 US Other 510(k) Applications for this Company
Contact	Darlene Phillips Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2019
Decision Date	03/14/2019
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