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FDA 510(k) Application Details - K110846
Device Classification Name
Urinalysis Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K110846
Device Name
Urinalysis Controls (Assayed And Unassayed)
Applicant
RANDOX LABORATORIES LIMITED
55 DIAMOND ROAD CRUMLIN
CRUMLIN 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
JJW
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More FDA Info for this Product Code
Date Received
03/28/2011
Decision Date
09/30/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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