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FDA 510(k) Application Details - K011648
Device Classification Name
Enzyme Immunoassay, Carbamazepine
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510(K) Number
K011648
Device Name
Enzyme Immunoassay, Carbamazepine
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, COUNTY ANTRIM BT29 4QY GB
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Contact
PAULINE ARMSTRONG
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Regulation Number
862.3645
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Classification Product Code
KLT
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More FDA Info for this Product Code
Date Received
05/29/2001
Decision Date
01/15/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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