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FDA 510(k) Application Details - K111904
Device Classification Name
Enzyme Immunoassay, Methotrexate
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510(K) Number
K111904
Device Name
Enzyme Immunoassay, Methotrexate
Applicant
ARK DIAGNOSTICS,INC
1190 BORDEAUX DRIVE
SUNNYVALE, CA 94089 US
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Contact
KENNETH C KASPER
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Regulation Number
000.0000
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Classification Product Code
LAO
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More FDA Info for this Product Code
Date Received
07/05/2011
Decision Date
10/18/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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