CHOLESTEROL ENZYMATIC ENDPOINT— 510(k) K923504
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K923504 for CHOLESTEROL ENZYMATIC ENDPOINT, Substantially Equivalent on 1994-01-10. Applicant: Randox Laboratories, Ltd.. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Antrim, N. Ireland, IR
Recent devices under product code CHH
view allMore clearances from Randox Laboratories, Ltd.
view allRecalls naming K923504
K-number listed on FDA's recall record- Z-1424-2022 — Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
- Z-0328-2022 — RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
- Z-1652-2016 — Advia Chemistry Assay: LDL Cholesterol, Direct
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923504.
Data sourced from openFDA. This site is unofficial and independent of the FDA.