Cleared Traditional

LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)

K133512 · Siemens Healthcare Diagnostics · Chemistry
Jan 2014
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K133512 is an FDA 510(k) clearance for the LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL), a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on January 2, 2014, 48 days after receiving the submission on November 15, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K133512 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2013
Decision Date January 02, 2014
Days to Decision 48 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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