Cleared Traditional

AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10

K062467 · Axis-Shield Diagnostics, Ltd. · Chemistry
Nov 2006
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K062467 is an FDA 510(k) clearance for the AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 22, 2006, 90 days after receiving the submission on August 24, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K062467 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2006
Decision Date November 22, 2006
Days to Decision 90 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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