FDA 510(k) Application Details - K990024

Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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510(K) Number K990024
Device Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
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 862.1050

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Classification Product Code CJE
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Date Received 01/05/1999
Decision Date 01/13/1999
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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