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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Partial Thromboplastin
510(k) Number K915463
Device Name ACTIVATED PARTIAL THROMBOPLASTIN TIME
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact DANIEL LAWSON
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact DANIEL LAWSON
Regulation Number864.7925
Classification Product Code
GGW  
Date Received12/04/1991
Decision Date 01/23/1992
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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