Cleared Traditional

DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR

K071224 · Dade Behring, Inc. · Chemistry
Nov 2007
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K071224 is an FDA 510(k) clearance for the DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on November 13, 2007, 195 days after receiving the submission on May 2, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K071224 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 2007
Decision Date November 13, 2007
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDD — Radioassay, Vitamin B12
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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