KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES— 510(k) K820263

Name: FDA 510(k) clearance K820263
Creator: U.S. Food and Drug Administration
Published: 1982-02-18

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K820263 for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES, Substantially Equivalent on 1982-02-18. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1982-02-02
Decision date: 1982-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CHH

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K251091 — Lipids2025-12-30
K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES2024-08-09
K203597 — Cholesterol22022-06-30
K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides2019-03-27
K181373 — Extended Lipid Panel Assay2018-10-18

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K060079 — KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM2006-02-08
K060055 — KODAK PACS2006-02-07
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Recalls naming K820263

K-number listed on FDA's recall record

Z-0304-2014 — VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and 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 K820263.

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