Cleared Traditional

J&S PEDIATRIC IRON SATURATING REAGENT

K910672 · J.S. Medical Assoc. · Chemistry

Apr 1991

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K910672 is an FDA 510(k) clearance for the J&S PEDIATRIC IRON SATURATING REAGENT, a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I — General Controls, product code JQE), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on April 29, 1991, 73 days after receiving the submission on February 15, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number	K910672 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1991
Decision Date	April 29, 1991
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JQE — Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1415