Cleared Traditional

K884649 - TOTAL IRON BINDING CAPACITY TEST
(FDA 510(k) Clearance)

K884649 · Sclavo, Inc. · Chemistry

Dec 1988

Decision

37d

Days

Class 1

Risk

K884649 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY TEST, a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I — General Controls, product code JQE), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on December 14, 1988, 37 days after receiving the submission on November 7, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number	K884649 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1988
Decision Date	December 14, 1988
Days to Decision	37 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