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FDA 510(k) Application Details - K131554
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
More FDA Info for this Device
510(K) Number
K131554
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
Other 510(k) Applications for this Company
Contact
PAULINE ARMSTRONG
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
05/30/2013
Decision Date
01/09/2014
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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