FDA 510(k) Application Details - K880796

Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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510(K) Number K880796
Device Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant TRACE AMERICA, INC.
P.O. BOX 45-1835
MIAMI, FL US
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Contact RAY LOPEZ
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Regulation Number 862.1050

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Classification Product Code CJE
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Date Received 02/26/1988
Decision Date 04/18/1988
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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