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510(k) K955851

AXSYM VANCOMYCIN II by Abbott Laboratories — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1996
Date Received
December 27, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Vancomycin
Device Class
Class II
Regulation Number
862.3950
Review Panel
TX
Submission Type

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