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FDA 510(k) Application Details - K011441
Device Classification Name
Azo Dye, Calcium
More FDA Info for this Device
510(K) Number
K011441
Device Name
Azo Dye, Calcium
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI, FL 33166 US
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Contact
David Johnston
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Regulation Number
862.1145
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Classification Product Code
CJY
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More FDA Info for this Product Code
Date Received
05/10/2001
Decision Date
07/09/2001
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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