KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL)— 510(k) K924471
Substantially EquivalentEastman Kodak Company
FDA 510(k) clearance K924471 for KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL), Substantially Equivalent on 1992-11-06. Applicant: Eastman Kodak Company. Device class: 2.
Clearance details
- Applicant
- Eastman Kodak Company
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code JGS
view allMore clearances from Eastman Kodak Company
view allAdverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K924471
K-number listed on FDA's recall record- Z-3280-2018 — VITROS Sodium Slides, Catalog # 837 9034
- Z-1087-2014 — VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K924471.
Data sourced from openFDA. This site is unofficial and independent of the FDA.