FDA device listing
ARCHITECT System,ARCHITECT System Accessories
FDA device listing 1351050201 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ARCHITECT System,ARCHITECT System Accessories |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | JJE |
| Device names | JJE - Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2160 |
| Review panels | Clinical Chemistry |
| Registered establishments | ABBOTT GmbH, ABBOTT IRELAND, ABBOTT LABORATORIES, Abbott Laboratories de Mexico |
| Establishment registrations | 1415939, 3002809144, 3005333358, 3008344661, 3016244760, 3016438761 |
| FEI numbers | 1415939, 3002809144, 3005333358, 3008344661, 3016244760, 3016438761 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database