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510(k) K853279

COXSACKIE A2 CF ANTIGEN, A4, A10 & A16 by Hillcrest Biologicals — Product Code GNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1985
Date Received
August 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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