KODAK EKTACHEM CLINICAL CHEM. NH3— 510(k) K820723

Name: FDA 510(k) clearance K820723
Creator: U.S. Food and Drug Administration
Published: 1982-04-01

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K820723 for KODAK EKTACHEM CLINICAL CHEM. NH3, Substantially Equivalent on 1982-04-01. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code JID
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 1982-03-16
Decision date: 1982-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K820723

K-number listed on FDA's recall record

Z-0297-2014 — VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.Class II·Terminated·Ortho-Clinical Diagnostics·20130612

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820723.

Data sourced from openFDA. This site is unofficial and independent of the FDA.