KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG)— 510(k) K861386

Name: FDA 510(k) clearance K861386
Creator: U.S. Food and Drug Administration
Published: 1986-08-26

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K861386 for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG), Substantially Equivalent on 1986-08-26. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1986-04-14
Decision date: 1986-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K861386

K-number listed on FDA's recall record

Z-0318-2014 — VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine 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 K861386.

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