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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Alpha-2-Antiplasmin
510(k) Number K864213
Device Name IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
Applicant
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Applicant Contact GEORGE A LYNA
Correspondent
Instrumentation Laboratory CO
113 Hartwell Ave.
P.O. Box 9113
Lexington,  MA  02173
Correspondent Contact GEORGE A LYNA
Regulation Number864.5425
Classification Product Code
LGP  
Date Received10/28/1986
Decision Date 11/25/1986
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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