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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
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