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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K983503
Device Name ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact JENNIFER L TRIBBETT
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact JENNIFER L TRIBBETT
Regulation Number862.1580
Classification Product Code
CEO  
Date Received10/06/1998
Decision Date 12/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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