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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 K803110
Device Name PROTEOLYTIC ENZYME CONTROL
Applicant
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Dade
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.5425
Classification Product Code
LGP  
Date Received12/10/1980
Decision Date 02/17/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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