PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED— 510(k) K942458
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K942458 for PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED, Substantially Equivalent on 1995-03-13. 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, IE
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More clearances from Randox Laboratories, Ltd.
view allRecalls naming K942458
K-number listed on FDA's recall record- Z-2150-2019 — Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
- Z-2768-2015 — MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
- Z-2316-2017 — MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K942458.
Data sourced from openFDA. This site is unofficial and independent of the FDA.