FDA 510(k) Application Details - K183375

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K183375
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant	Horiba, Ltd 2 Miyanohigashi, Kisshoin, Minami-ku Kyoto 601-8510 JP Other 510(k) Applications for this Company
Contact	Naoyuki Nomura Other 510(k) Applications for this Contact
Regulation Number	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2018
Decision Date	02/12/2019
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