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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
510(k) Number K823111
Device Name NYSTYMOGRAPH ACCESS
Applicant
Kelleher Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Kelleher Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.3145
Classification Product Code
GNN  
Date Received10/25/1982
Decision Date 11/22/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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