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FDA 510(k) Application Details - K012396
Device Classification Name
Enzyme Immunoassay, Amphetamine
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510(K) Number
K012396
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46256 US
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Contact
JENNIFER TRIBBETT
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Regulation Number
862.3100
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Classification Product Code
DKZ
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More FDA Info for this Product Code
Date Received
07/27/2001
Decision Date
11/05/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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