RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL— 510(k) K140522
Substantially EquivalentRandox Laboratories Limited
FDA 510(k) clearance K140522 for RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL, Substantially Equivalent on 2014-05-22. 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 K140522
K-number listed on FDA's recall record- Z-2021-2023 — Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
- Z-2022-2023 — Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
- Z-1106-2019 — Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
- Z-0969-2018 — Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
- Z-0970-2018 — Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140522.
Data sourced from openFDA. This site is unofficial and independent of the FDA.