FDA device listing
BIO-FLASH System Rinse,HemosIL Acustar System Rinse
FDA device listing 2023151601 · Instrumentation Laboratory SpA
Key facts
| Proprietary names | BIO-FLASH System Rinse,HemosIL Acustar System Rinse |
|---|---|
| Owner/operator | Instrumentation Laboratory SpA |
| Owner/operator number | 10082968 |
| Premarket submissions | K170314 |
| Product codes | JPA |
| Device names | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.5425 |
| Review panels | Hematology |
| Registered establishments | Instrumentation Laboratory SpA, INSTRUMENTATION LABORATORY SPA |
| Establishment registrations | 3007719797, 3012348571 |
| FEI numbers | 3007719797, 3012348571 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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