ADVIA Centaur Erythropoietin (EPO) assay— 510(k) K183088
Substantially EquivalentAxis-Shield Diagnostics Limited
FDA 510(k) clearance K183088 for ADVIA Centaur Erythropoietin (EPO) assay, Substantially Equivalent on 2019-08-02. Applicant: Axis-Shield Diagnostics Limited. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Diagnostics Limited
- Product code
- Code GGT
- Device class
- Class 2
- Regulation
- 21 CFR 864.7250
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dundee, GB
Recent devices under product code GGT
view allMore clearances from Axis-Shield Diagnostics Limited
view all- K182012 — ADVIA Centaur Calcitonin (CALCT) assay
- K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.
- K160757 — ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
Recalls naming K183088
K-number listed on FDA's recall record- Z-1280-2024 — Atellica IM Erythropoietin (EPO) Assay (100 Test)
- Z-1281-2024 — ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183088.
Data sourced from openFDA. This site is unofficial and independent of the FDA.