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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sera, Animal And Human
510(k) Number K810478
Device Name ANIMAL SERUM PRODUCTS
Applicant
Animal Health Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Animal Health Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.2800
Classification Product Code
KIS  
Date Received02/23/1981
Decision Date 04/08/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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