K-ASSAY CRP CALIBRATOR SET— 510(k) K991210
Substantially EquivalentKamiya Biomedical Co.
FDA 510(k) clearance K991210 for K-ASSAY CRP CALIBRATOR SET, Substantially Equivalent on 1999-05-11. Applicant: Kamiya Biomedical Co.. Device class: 2.
Clearance details
- Applicant
- Kamiya Biomedical Co.
- 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
- Seattle, WA, US
Recent devices under product code DCK
view allMore 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
- K050944 — K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.