RANDOX FERRITIN— 510(k) K000662
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K000662 for RANDOX FERRITIN, Substantially Equivalent on 2000-04-03. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, Co. Antrim, IE
Recent devices under product code DBF
view all- K193650 — LIAISON Ferritin
- K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K171642 — Atellica IM Ferritin Assay
- K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- K121232 — K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
More clearances from Randox Laboratories, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.