Cleared Traditional

KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT

K933329 · King Diagnostics, Inc. · Chemistry
Oct 1993
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K933329 is an FDA 510(k) clearance for the KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 22, 1993, 106 days after receiving the submission on July 8, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K933329 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 1993
Decision Date October 22, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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