FDA device listing
60-OX0480 Pointe Oxycodone Reagent,60-OX0484 Pointe Oxycodone Control (75 ng/mL),60-OX0486 Pointe Oxycodone Calibrator…
FDA device listing 1566531423 · HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical
Key facts
| Proprietary names | 60-OX0480 Pointe Oxycodone Reagent,60-OX0484 Pointe Oxycodone Control (75 ng/mL),60-OX0486 Pointe Oxycodone Calibrator (100 ng/mL),60-OX0488 Pointe Oxycodone Control (125 ng/mL),60-OX0490 Pointe Oxycodone Control (225 ng/mL),60-OX0492 Pointe Oxycodone Calibrator (300 ng/mL),60-OX0494 Pointe Oxycodone Control (375 ng/mL),60-OX0496 Pointe Oxycodone Calibrator (500 ng/mL),60-OX0498 Pointe Oxycodone… |
|---|---|
| Owner/operator | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
| Owner/operator number | 10083022 |
| Premarket submissions | K120763 |
| Product codes | DJG, DLJ, LAS |
| Device names | DJG - Enzyme Immunoassay, Opiates, DLJ - Calibrators, Drug Specific, LAS - Drug Specific Control Materials |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.3200, 862.3280, 862.3650 |
| Review panels | Clinical Toxicology |
| Registered establishments | HORIBA INSTRUMENTS INCORPORATED |
| Establishment registrations | 1827821 |
| FEI numbers | 1827821 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| 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