Cleared Traditional

DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

K081299 · Siemens Healthcare Diagnostics, Inc. · Immunology
Aug 2008
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K081299 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 8, 2008, 92 days after receiving the submission on May 8, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K081299 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2008
Decision Date August 08, 2008
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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