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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 K853803
Device Name FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
Applicant
Z.L. Bocknek Laboratories, Inc.
165 Bethridge Rd.
Rexdale, Toronto Ontario
Canada Maw In1,  CA
Applicant Contact PAUL HAFFENDEN
Correspondent
Z.L. Bocknek Laboratories, Inc.
165 Bethridge Rd.
Rexdale, Toronto Ontario
Canada Maw In1,  CA
Correspondent Contact PAUL HAFFENDEN
Regulation Number864.2800
Classification Product Code
KIS  
Date Received09/11/1985
Decision Date 10/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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