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510(k) K964587

VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM by Bayer Corp. — Product Code LEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1997
Date Received
November 15, 1996
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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  • K032811 — CEDIA VANCOMYCIN ASSAY (November 24, 2003)