Cleared Traditional

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

K081249 · Dade Behring, Inc. · Immunology
Jul 2008
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K081249 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 21, 2008, 80 days after receiving the submission on May 2, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.

Submission Details

510(k) Number K081249 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2008
Decision Date July 21, 2008
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5620

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