Cleared Traditional

TEST, FERROZINE IRON & IRON BINDING

K770748 · Hycel, Inc. · Chemistry
Jun 1977
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K770748 is an FDA 510(k) clearance for the TEST, FERROZINE IRON & IRON BINDING, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1977, 40 days after receiving the submission on April 22, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K770748 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1977
Decision Date June 01, 1977
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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