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FDA 510(k) Application Details - K042520
Device Classification Name
Enzyme Immunoassay, Theophylline
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510(K) Number
K042520
Device Name
Enzyme Immunoassay, Theophylline
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
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Contact
CAREY A MAYO
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Regulation Number
862.3880
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Classification Product Code
KLS
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More FDA Info for this Product Code
Date Received
09/16/2004
Decision Date
11/30/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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