RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3— 510(k) K110904
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K110904 for RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3, Substantially Equivalent on 2011-09-30. Applicant: Randox Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- 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 K110904
K-number listed on FDA's recall record- Z-2446-2023 — Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems Catalog Number: UC5074
- Z-2167-2017 — Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110904.
Data sourced from openFDA. This site is unofficial and independent of the FDA.