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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K872328
Device Name DIGOXIN FPIA CALIBRATORS
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact DENNIS MURRAY
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact DENNIS MURRAY
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received06/17/1987
Decision Date 07/07/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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