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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conductivity Rate, Urea Nitrogen
510(k) Number K963537
Device Name SIGMA DIAGNOSTICS BUN REAGENT
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number862.1770
Classification Product Code
LFP  
Date Received09/04/1996
Decision Date 10/24/1996
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
Predetermined Change
Control Plan Authorized		 No
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