Cleared Traditional

DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH

K063272 · Dade Behring, Inc. · Immunology
Jan 2007
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K063272 is an FDA 510(k) clearance for the DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on January 26, 2007, 88 days after receiving the submission on October 30, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K063272 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2006
Decision Date January 26, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZG — System, Test, Beta-2-microglobulin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5630

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