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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (U.V.)
510(k) Number K982251
Device Name SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST.LOUIS,  MO  63103
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST.LOUIS,  MO  63103
Regulation Number862.1775
Classification Product Code
CDO  
Date Received06/26/1998
Decision Date 08/18/1998
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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