ABX PENTRA 400: LIPOPROTEINS— 510(k) K060854
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K060854 for ABX PENTRA 400: LIPOPROTEINS, Substantially Equivalent on 2006-08-24. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code JIT
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view all- K073309 — ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
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- 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 K060854
K-number listed on FDA's recall record- Z-0738-2016 — The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
- Z-0742-2016 — ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060854.
Data sourced from openFDA. This site is unofficial and independent of the FDA.