ABX PENTRA 400 : CRP— 510(k) K061138
Substantially EquivalentHoriba Abx
FDA 510(k) clearance K061138 for ABX PENTRA 400 : CRP, Substantially Equivalent on 2006-09-29. Applicant: Horiba Abx. Device class: 2.
Clearance details
- Applicant
- Horiba Abx
- Product code
- Code DCK
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Montpellier, FR
Recent devices under product code DCK
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.