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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 K905301
Device Name THE THERATEST ACA TEST
Applicant
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Applicant Contact MARIUS TEODORESCU
Correspondent
Theratest Laboratories, Inc.
2201 W. Campbell Park Dr.
Chicago,  IL  60612
Correspondent Contact MARIUS TEODORESCU
Regulation Number864.7925
Classification Product Code
GFO  
Date Received11/27/1990
Decision Date 01/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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