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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 K833890
Device Name COATEST ANTIPLASMIN
Applicant
Kabivitrum, Inc.
Anaheim,  CA 
Correspondent
Kabivitrum, Inc.
Anaheim,  CA 
Regulation Number864.5425
Classification Product Code
LGP  
Date Received11/09/1983
Decision Date 01/30/1984
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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