FDA device listing
H7541-CAL Pointe Hemoglobin A1c Calibrator,H7541-CTL Pointe Hemoglobin A1c Controls,H7541 Pointe Hemoglobin A1c…
FDA device listing 1516016289 · HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Key facts
| Proprietary names | H7541-CAL Pointe Hemoglobin A1c Calibrator,H7541-CTL Pointe Hemoglobin A1c Controls,H7541 Pointe Hemoglobin A1c Reagent,H7546 Pointe Hemoglobin A1c Reagent |
|---|---|
| Owner/operator | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
| Owner/operator number | 10083022 |
| Premarket submissions | K031539 |
| Product codes | LCP |
| Device names | LCP - Assay, Glycosylated Hemoglobin |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.7470 |
| Review panels | Hematology |
| Registered establishments | HORIBA INSTRUMENTS INCORPORATED |
| Establishment registrations | 1827821 |
| FEI numbers | 1827821 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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