Cleared Traditional

BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)

K012340 · Bayer Corp. · Chemistry
Oct 2001
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K012340 is an FDA 510(k) clearance for the BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC), a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 1, 2001, 69 days after receiving the submission on July 24, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K012340 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2001
Decision Date October 01, 2001
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JMO — Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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