FDA 510(k) Application Details - K003912

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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510(K) Number K003912
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI, FL 33166 US
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Contact David Johnston
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Regulation Number 862.1580

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Classification Product Code CEO
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Date Received 12/19/2000
Decision Date 02/21/2001
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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