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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 K933679
Device Name SIGMA BUN REAGENT
Applicant
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
Sigma Chemical Co.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number862.1770
Classification Product Code
LFP  
Date Received07/28/1993
Decision Date 12/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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