RX IMOLA— 510(k) K052914
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K052914 for RX IMOLA, Substantially Equivalent on 2006-03-31. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
Recent devices under product code CEM
view allMore clearances from Randox Laboratories, Ltd.
view allRecalls naming K052914
K-number listed on FDA's recall record- Z-0200-2024 — RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
- Z-2084-2019 — RX Imola, Model Nos. RX4900
- Z-2059-2018 — RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
- Z-0725-2017 — Magnesium on RX Imola analyser IVD
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052914.
Data sourced from openFDA. This site is unofficial and independent of the FDA.