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FDA 510(k) Application Details - K063144
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
More FDA Info for this Device
510(K) Number
K063144
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
Ortho-Clinical Diagnostics, Inc.
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
Other 510(k) Applications for this Company
Contact
SARAH C PARSONS
Other 510(k) Applications for this Contact
Regulation Number
862.2160
More FDA Info for this Regulation Number
Classification Product Code
JJE
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More FDA Info for this Product Code
Date Received
10/16/2006
Decision Date
11/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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