Cleared Traditional

K870035 - KODAK EKTACHEM DT SLIDES (CA)
(FDA 510(k) Clearance)

K870035 · Eastman Kodak Company · Chemistry
May 1987
Decision
127d
Days
Class 2
Risk

K870035 is an FDA 510(k) clearance for the KODAK EKTACHEM DT SLIDES (CA), a Alizarin Sulfonate, Calcium (Class II — Special Controls, product code CID), submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on May 12, 1987, 127 days after receiving the submission on January 5, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.

Submission Details

510(k) Number K870035 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1987
Decision Date May 12, 1987
Days to Decision 127 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CID — Alizarin Sulfonate, Calcium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1145