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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Thromboplastin And Control
510(k) Number K010158
Device Name THROMBOMAX-HS WITH CALCIUM, MODEL T6540
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAM R GILBERT II
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAM R GILBERT II
Regulation Number864.7925
Classification Product Code
GGO  
Date Received01/17/2001
Decision Date 03/22/2001
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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