FDA 510(k) Application Details - K864905

Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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510(K) Number K864905
Device Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant TECH-CO, INC.
4378 REILLY
TROY, MI US
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Contact HAPPY CHEN
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Regulation Number 862.1050

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Classification Product Code CJE
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Date Received 12/15/1986
Decision Date 01/13/1987
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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