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FDA 510(k) Application Details - K112834
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K112834
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
VERICHEM LABORATORIES, INC.
90 NARRAGANSETT AVE.
PROVIDENCE, RI 02907 US
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Contact
ANTHONY JAMES DIMONTE
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Regulation Number
862.1150
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Classification Product Code
JIX
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More FDA Info for this Product Code
Date Received
09/28/2011
Decision Date
03/28/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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