Cleared Traditional

KODAK EKTACHEM DT SLIDES (FE)

K934358 · Eastman Kodak Company · Chemistry

Mar 1994

Decision

194d

Days

Class 1

Risk

About This 510(k) Submission

K934358 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (FE), a Resin, Ion-exchange, Ascorbic Acid, Colorimetry, Iron Binding Capacity (Class I — General Controls, product code JQE), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 21, 1994, 194 days after receiving the submission on September 8, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number	K934358 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 1993
Decision Date	March 21, 1994
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

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