ARCHITECT B12— 510(k) K121314
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K121314 for ARCHITECT B12, Substantially Equivalent on 2012-05-17. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- 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
- Traditional
- Location
- Abbott Park, IL, 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 Abbott Laboratories
view allData sourced from openFDA. This site is unofficial and independent of the FDA.