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FDA 510(k) Application Details - K121027
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K121027
Device Name
Calibrator, Secondary
Applicant
DIAMOND DIAGNOSTICS, INC
333 Fiske St
Holliston, MA 01746 US
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Contact
KATHY CRUZ
Other 510(k) Applications for this Contact
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
04/04/2012
Decision Date
12/20/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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