Cleared Traditional

KODAK EKTACHEM CLINICAL CHEM. NH3

K820723 · Eastman Kodak Company · Chemistry
Apr 1982
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K820723 is an FDA 510(k) clearance for the KODAK EKTACHEM CLINICAL CHEM. NH3, a Photometric Method, Ammonia (Class I — General Controls, product code JID), submitted by Eastman Kodak Company (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982, 16 days after receiving the submission on March 16, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K820723 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1982
Decision Date April 01, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JID — Photometric Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065