EKTACHEM CLINICAL CHEM. SLIDES— 510(k) K840606
Substantially EquivalentEastman Kodak Company
FDA 510(k) clearance K840606 for EKTACHEM CLINICAL CHEM. SLIDES, Substantially Equivalent on 1984-04-04. Applicant: Eastman Kodak Company. Device class: 2.
Clearance details
- Applicant
- Eastman Kodak Company
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code CIG
view allMore clearances from Eastman Kodak Company
view allRecalls naming K840606
K-number listed on FDA's recall record- Z-2874-2020 — VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
- Z-0300-2014 — VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma 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 K840606.
Data sourced from openFDA. This site is unofficial and independent of the FDA.