RANDOX LIQUID PROTEIN CALIBRATOR— 510(k) K061056
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K061056 for RANDOX LIQUID PROTEIN CALIBRATOR, Substantially Equivalent on 2006-07-20. 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 K061056
K-number listed on FDA's recall record- Z-1328-2024 — Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.
- Z-2448-2023 — Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgM, Prealbumin, RF and Transferrin assays Catalogue Number: IT2691
- Z-0283-2020 — Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061056.
Data sourced from openFDA. This site is unofficial and independent of the FDA.