FDA device listing
Vacutainer Luer-Lok Access Device - Tubes, vials, systems, serum separators, blood collection
FDA device listing 1147834134 · Platinum Focus Group Ltd.
Key facts
| Proprietary names | Vacutainer Luer-Lok Access Device - Tubes, vials, systems, serum separators, blood collection |
|---|---|
| Owner/operator | Platinum Focus Group Ltd. |
| Owner/operator number | 10089900 |
| Product codes | JKA |
| Device names | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | PLATINUM FOCUS GROUP LTD. |
| Establishment registrations | 3030446844 |
| FEI numbers | 3030446844 |
| Establishment operations | Contract Sterilizer |
| 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