LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.— 510(k) K140971
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K140971 for LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3., Substantially Equivalent on 2014-12-08. Applicant: Randox Laboratories Limited. Device class: 1.
Clearance details
- Applicant
- Randox Laboratories Limited
- 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 Limited
view allRecalls naming K140971
K-number listed on FDA's recall record- Z-2609-2023 — Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Z-1547-2020 — Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140971.
Data sourced from openFDA. This site is unofficial and independent of the FDA.