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510(k) K974456

CMVGEN by Instrumentation Laboratory CO — Product Code LJO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1998
Date Received
November 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Iha, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
Submission Type

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Other clearances for product code LJO

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