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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
510(k) Number K813512
Device Name RHESUS MONKEY BLOOD IN ALSEVER'S
Applicant
Dutchland Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dutchland Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3720
Classification Product Code
LHW  
Date Received12/15/1981
Decision Date 12/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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