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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K933678
Device Name SIGMA CALCIUM 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 Number862.1145
Classification Product Code
CJY  
Date Received07/29/1993
Decision Date 03/11/1994
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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