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510(k) K062773

MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN by Dade Behring, Inc. — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 2006
Date Received
September 18, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panels, Test, Susceptibility, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

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