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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Thrombin Time
510(k) Number K982209
Device Name ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAN R GILBERT
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAN R GILBERT
Regulation Number864.7875
Classification Product Code
GJA  
Date Received06/23/1998
Decision Date 10/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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