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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K781654
Device Name NEPHELRATE ANTIPERUMS LGM
Applicant
ANTIBODIES INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ANTIBODIES INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number866.5510
Classification Product Code
CFN  
Date Received09/27/1978
Decision Date 11/08/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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