Cleared Traditional

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

K081161 · Dade Behring, Inc. · Immunology
Jul 2008
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K081161 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 28, 2008, 95 days after receiving the submission on April 24, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K081161 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2008
Decision Date July 28, 2008
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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