K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET— 510(k) K050944
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K050944 for K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET, Substantially Equivalent on 2005-12-23. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- 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
- Tukwila, WA, US
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 Kamiya Biomedical Co.
view all- K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
- K091486 — K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
- K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
- K030687 — K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C
- K023828 — K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR
Data sourced from openFDA. This site is unofficial and independent of the FDA.