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FDA 510(k) Application Details - K992475
Device Classification Name
Enzymatic, Carbon-Dioxide
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510(K) Number
K992475
Device Name
Enzymatic, Carbon-Dioxide
Applicant
CARESIDE, INC.
6100 BRISTOL PKWY.
CULVER CITY, CA 90230 US
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Contact
KENNETH B ASARCH
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Regulation Number
862.1160
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Classification Product Code
KHS
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More FDA Info for this Product Code
Date Received
07/26/1999
Decision Date
09/15/1999
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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