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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K992800
Device Name SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
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
CDQ  
Date Received08/19/1999
Decision Date 09/28/1999
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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