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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 K003012
Device Name RAICHEM PHOSPORUS REAGENT
Applicant
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Applicant Contact JOSE A MONTANEZ
Correspondent
HEMAGEN DIAGNOSTICS, INC.
9033 RED BRANCH RD.
COLUMBIA,  MD  21045
Correspondent Contact JOSE A MONTANEZ
Regulation Number862.1580
Classification Product Code
CEO  
Date Received09/26/2000
Decision Date 10/25/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
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