FDA 510(k) Application Details - K983503

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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510(K) Number K983503
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS, IN 46250-0457 US
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Contact JENNIFER L TRIBBETT
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Regulation Number 862.1580

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Classification Product Code CEO
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Date Received 10/06/1998
Decision Date 12/01/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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