GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER— 510(k) K060205
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K060205 for GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER, Substantially Equivalent on 2006-07-21. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code CJE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code CJE
view allMore clearances from Horiba Abx
view all- K073309 — ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
- K081276 — ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
- K071779 — ABX PENTRA URINE CAL
- K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H
- K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
Recalls naming K060205
K-number listed on FDA's recall record- Z-1140-2022 — ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
- Z-2692-2014 — ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060205.
Data sourced from openFDA. This site is unofficial and independent of the FDA.