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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K811784
Device Name SIGMA PROCEDURE #890
Applicant
SIGMA CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SIGMA CHEMICAL CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/23/1981
Decision Date 07/27/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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