RANDOX CALIBRATION SERUM— 510(k) K053153
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K053153 for RANDOX CALIBRATION SERUM, Substantially Equivalent on 2006-01-13. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, GB
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More clearances from Randox Laboratories, Ltd.
view allRecalls naming K053153
K-number listed on FDA's recall record- Z-1759-2024 — Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
- Z-0752-2024 — Calibration Serum Level 3 CAL2351
- Z-0753-2024 — Calibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry assays Catalog Number: CAL2351
- Z-0751-2024 — Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)
- Z-1563-2021 — Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351
- Z-2490-2019 — This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053153.
Data sourced from openFDA. This site is unofficial and independent of the FDA.