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FDA 510(k) Application Details - K003012
Device Classification Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
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510(K) Number
K003012
Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA, MD 21045 US
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Contact
JOSE A MONTANEZ
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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
09/26/2000
Decision Date
10/25/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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