FDA 510(k) Application Details - K880344

Device Classification Name Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes

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510(K) Number K880344
Device Name Phenolphthalein Phosphate, Alkaline Phosphatase Or Isoenzymes
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
1 BECTON DR.
FRANKLIN LAKES, NJ US
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Contact J ARNSBERGER
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Regulation Number 862.1050

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Classification Product Code CJK
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Date Received 01/26/1988
Decision Date 03/01/1988
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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