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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 K973306
Device Name IL TEST APTT-SP
Applicant
Instrumentation Laboratory CO
526 Rt. 303
Orangeburg,  NY  10962
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
526 Rt. 303
Orangeburg,  NY  10962
Correspondent Contact CAROL MARBLE
Regulation Number864.7925
Classification Product Code
GFO  
Date Received09/03/1997
Decision Date 11/04/1997
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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