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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K843215
Device Name FACTOR IX DEFICIENT PLASMA, B9D -
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact DEO BRESSLER
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact DEO BRESSLER
Regulation Number864.7290
Classification Product Code
GGP  
Date Received08/15/1984
Decision Date 11/19/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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