FDA device listing
Blood Glucose Monitoring System
FDA device listing 1128948714 · New Pentastar Medical Products Co. Limited
Key facts
| Proprietary names | Blood Glucose Monitoring System |
|---|---|
| Owner/operator | New Pentastar Medical Products Co. Limited |
| Owner/operator number | 10063374 |
| Premarket submissions | K153561 |
| Product codes | LFR, NBW |
| Device names | LFR - Glucose Dehydrogenase, Glucose, NBW - System, Test, Blood Glucose, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1345 |
| Review panels | Clinical Chemistry |
| Registered establishments | JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. |
| Establishment registrations | 3015058854 |
| FEI numbers | 3015058854 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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