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510(k) K081161

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST by Dade Behring, Inc. — Product Code CFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2008
Date Received
April 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
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  • K072717 — DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 (December 12, 2007)

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