ACCELERATOR APS— 510(k) K093318
Substantially EquivalentAbbott Laboratories
FDA 510(k) clearance K093318 for ACCELERATOR APS, Substantially Equivalent on 2010-02-19. Applicant: Abbott Laboratories. Device class: 2.
Clearance details
- Applicant
- Abbott Laboratories
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irving, TX, US
Recent devices under product code CEM
view allMore clearances from Abbott Laboratories
view allRecalls naming K093318
K-number listed on FDA's recall record- Z-2251-2020 — Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.
- Z-2755-2019 — APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093318.
Data sourced from openFDA. This site is unofficial and independent of the FDA.