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510(k) K823111

NYSTYMOGRAPH ACCESS by Kelleher Corp. — Product Code GNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
October 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6
Device Class
Class I
Regulation Number
866.3145
Review Panel
MI
Submission Type

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