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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 K861048
Device Name PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765
Applicant
Sigma Chemical Co.
Post Office Box 14508
St. Louis,  MO  63278
Applicant Contact LEO BRESSLER
Correspondent
Sigma Chemical Co.
Post Office Box 14508
St. Louis,  MO  63278
Correspondent Contact LEO BRESSLER
Regulation Number864.7290
Classification Product Code
GGP  
Date Received03/19/1986
Decision Date 05/29/1986
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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