Cleared Traditional

DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H

K071980 · Dade Behring, Inc. · Immunology
Sep 2007
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K071980 is an FDA 510(k) clearance for the DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on September 11, 2007, 55 days after receiving the submission on July 18, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K071980 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2007
Decision Date September 11, 2007
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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