FDA 510(k) Application Details - K934588

Device Classification Name Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride

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510(K) Number K934588
Device Name Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
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 862.1170

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Classification Product Code CHG
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Date Received 09/23/1993
Decision Date 02/18/1994
Decision SE - Substantially Equivalent
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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