Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents— 510(k) K140496
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K140496 for Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents, Substantially Equivalent on 2014-09-16. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brea, CA, US
Recent devices under product code CDD
view all- K233541 — ARCHITECT Active-B12 (Holotranscobalamin)
- K223289 — Access Vitamin B12
- K190298 — DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
- K192064 — LIAISON Vitamin B12
- K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
More clearances from Beckman Coulter, Inc.
view allRecalls naming K140496
K-number listed on FDA's recall record- Z-2978-2024 — Power Express, REF B90918
- Z-2979-2024 — PE Centrifuge, REF: B36365, a component of the Power Express
- Z-2980-2024 — PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
- Z-1741-2020 — Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140496.
Data sourced from openFDA. This site is unofficial and independent of the FDA.