Cleared Traditional

ALFERR TIBC TUBE

K864548 · Benchmark Reagents · Chemistry

Feb 1987

Decision

75d

Days

Class 1

Risk

About This 510(k) Submission

K864548 is an FDA 510(k) clearance for the ALFERR TIBC TUBE, a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I — General Controls, product code JQE), submitted by Benchmark Reagents (Australia, AU). The FDA issued a Cleared decision on February 2, 1987, 75 days after receiving the submission on November 19, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number	K864548 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1986
Decision Date	February 02, 1987
Days to Decision	75 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