KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)— 510(k) K932728

Name: FDA 510(k) clearance K932728
Creator: U.S. Food and Drug Administration
Published: 1994-04-25

Substantially Equivalent

Eastman Kodak Company

FDA 510(k) clearance K932728 for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC), Substantially Equivalent on 1994-04-25. Applicant: Eastman Kodak Company. Device class: 1.

Clearance details

Applicant: Eastman Kodak Company
Product code: Code KNK
Device class: Class 1
Regulation: 21 CFR 862.1775
Advisory panel: Clinical Chemistry
Date received: 1993-06-07
Decision date: 1994-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K932728

K-number listed on FDA's recall record

Z-0092-2017 — VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides per sales unit), Unique Device Identifier No. 10758750000340, Rx ONLY, IVD --- For in vitro diagnostic use only.Class II·Terminated·Ortho-Clinical Diagnostics·20160811

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K932728.

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