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FDA 510(k) Application Details - K011393
Device Classification Name
Enzyme Immunoassay, Diphenylhydantoin
More FDA Info for this Device
510(K) Number
K011393
Device Name
Enzyme Immunoassay, Diphenylhydantoin
Applicant
RANDOX LABORATORIES, LTD.
55 DIAMOND RD.
CRUMLIN, CO. ANTRIM BT29 4QY IE
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Contact
P. ARMSTRONG
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Regulation Number
862.3350
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Classification Product Code
DIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2001
Decision Date
12/04/2001
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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