FDA 510(k) Application Details - K974858

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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510(K) Number K974858
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant DIAGNOSTIC CHEMICALS LTD.
WEST ROYALTY INDUSTRIAL PARK,
CHARLOTTETOWN, P.E.I. C1E 2A6 CA
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Contact KAREN CALLBECK
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Regulation Number 862.1580

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Classification Product Code CEO
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Date Received 12/29/1997
Decision Date 01/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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