FDA device listing
Pointe 180 II Chemistry Analyzer,Pointe 180 Plus Chemistry Analyzer,Pointe 180 QT Chemistry Analyzer
FDA device listing 1890557611 · HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Key facts
| Proprietary names | Pointe 180 II Chemistry Analyzer,Pointe 180 Plus Chemistry Analyzer,Pointe 180 QT Chemistry Analyzer |
|---|---|
| Owner/operator | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
| Owner/operator number | 10083022 |
| Product codes | JJQ |
| Device names | JJQ - Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2300 |
| Review panels | Clinical Chemistry |
| Registered establishments | HORIBA INSTRUMENTS INCORPORATED |
| Establishment registrations | 1827821 |
| FEI numbers | 1827821 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| 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