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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Complement
510(k) Number K812522
Device Name RABBIT COMPLEMENT
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 Number866.4100
Classification Product Code
KTQ  
Date Received09/02/1981
Decision Date 09/23/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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