Cleared Traditional

DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH

K061852 · Dade Behring, Inc. · Immunology
Sep 2006
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K061852 is an FDA 510(k) clearance for the DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on September 22, 2006, 84 days after receiving the submission on June 30, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K061852 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2006
Decision Date September 22, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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