Cleared Traditional

IRON REAGENTS PRODUCT CODES 7725 AND 7726

K901960 · American Research Products Co. · Chemistry
May 1990
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K901960 is an FDA 510(k) clearance for the IRON REAGENTS PRODUCT CODES 7725 AND 7726, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on May 31, 1990, 30 days after receiving the submission on May 1, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K901960 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1990
Decision Date May 31, 1990
Days to Decision 30 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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