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FDA 510(k) Application Details - K053291
Device Classification Name
Calibrator, Secondary
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510(K) Number
K053291
Device Name
Calibrator, Secondary
Applicant
REFERENCE DIAGNOSTICS, INC.
19 CROSBY DR. SUITE 30
BEDFORD, MA 01730 US
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Contact
JOSEPH LAWLOR
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Regulation Number
862.1150
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Classification Product Code
JIT
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More FDA Info for this Product Code
Date Received
11/25/2005
Decision Date
03/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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