Cleared Traditional

DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

K083463 · Siemens Healthcare Diagnostics · Immunology
Mar 2009
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K083463 is an FDA 510(k) clearance for the DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M, a System, Test, Beta-2-microglobulin Immunological (Class II — Special Controls, product code JZG), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 13, 2009, 109 days after receiving the submission on November 24, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5630.

Submission Details

510(k) Number K083463 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2008
Decision Date March 13, 2009
Days to Decision 109 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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