FDA device listing
Cuvette Conditioner EX,Cuvette Wash Solution 7,ISE Buffer (IS),ISE Detergent Solution,Lamp Coolant C,Reagent Probe Wash…
FDA device listing 1492831428 · HORIBA LTD.
Key facts
| Proprietary names | Cuvette Conditioner EX,Cuvette Wash Solution 7,ISE Buffer (IS),ISE Detergent Solution,Lamp Coolant C,Reagent Probe Wash 1,Reagent Probe Wash 2,Reagent Probe Wash K,Reagent Probe Wash S |
|---|---|
| Owner/operator | HORIBA LTD. |
| Owner/operator number | 9052537 |
| Product codes | PPM |
| Device names | PPM - General Purpose Reagent |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | HORIBA LTD. |
| Establishment registrations | 1000256526 |
| FEI numbers | 1000256526 |
| Establishment operations | Foreign Exporter |
| 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