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FDA 510(k) Application Details - K140971
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
More FDA Info for this Device
510(K) Number
K140971
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND RD.
CRUMLIN, CO.ANTRIM BT29 4QY GB
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Contact
PAULINE ARMSTRONG
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/16/2014
Decision Date
12/08/2014
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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