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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plates And Equipment, Radial Immunodiffusion
510(k) Number K770548
Device Name IMMUNOPLATE III RADIO IMMUNODIFFUSION
Applicant
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.4800
Classification Product Code
JZQ  
Date Received03/21/1977
Decision Date 04/15/1977
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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