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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 K823580
Device Name COBAS REAGENT FOR INORGANIC PHOSPHORUS
Applicant
HOFFMANN-LA ROCHE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HOFFMANN-LA ROCHE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1580
Classification Product Code
CEO  
Date Received12/06/1982
Decision Date 01/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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