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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K003329
Device Name SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAM R GILBERT
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAM R GILBERT
Regulation Number864.5425
Classification Product Code
GGC  
Date Received10/24/2000
Decision Date 03/01/2001
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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