Yumizen C1200 CRP— 510(k) K191993
Substantially EquivalentHORIBA ABX SAS
FDA 510(k) clearance K191993 for Yumizen C1200 CRP, Substantially Equivalent on 2019-10-03. Applicant: HORIBA ABX SAS. Device class: 2.
Clearance details
- Applicant
- HORIBA ABX SAS
- 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 Cedex 4, FR
Recent devices under product code DCK
view allMore clearances from HORIBA ABX SAS
view all- K232946 — Yumizen H2500
- K193649 — Yumizen C1200 Creatinine PAP
- K193525 — Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
- K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
- K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin
Data sourced from openFDA. This site is unofficial and independent of the FDA.