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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Partial Thromboplastin
510(k) Number K992711
Device Name SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
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 Number864.7925
Classification Product Code
GFO  
Date Received08/11/1999
Decision Date 12/06/1999
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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