Cleared Traditional

KODAK EKTA-CHEM CLINICAL CHEM. SLIDES

K802376 · Eastman Kodak Company · Chemistry
Oct 1980
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K802376 is an FDA 510(k) clearance for the KODAK EKTA-CHEM CLINICAL CHEM. SLIDES, a Coulometric Method, Carbon-dioxide (Class II — Special Controls, product code CHS), submitted by Eastman Kodak Company (Walker, US). The FDA issued a Cleared decision on October 23, 1980, 23 days after receiving the submission on September 30, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K802376 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1980
Decision Date October 23, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CHS — Coulometric Method, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160