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FDA 510(k) Application Details - K020454
Device Classification Name
Calibrator, Secondary
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510(K) Number
K020454
Device Name
Calibrator, Secondary
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI, FL 33166 US
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Contact
David Johnston
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
02/11/2002
Decision Date
04/08/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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