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FDA 510(k) Application Details - K974858
Device Classification Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
862.1580
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Classification Product Code
CEO
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More FDA Info for this Product Code
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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