FDA device listing
OC-Sensor DIANA iFOB Test
FDA device listing 1923661176 · EIKEN CHEMICAL CO., LTD.
Key facts
| Proprietary names | OC-Sensor DIANA iFOB Test |
|---|---|
| Owner/operator | EIKEN CHEMICAL CO., LTD. |
| Owner/operator number | 8031541 |
| Premarket submissions | K092330 |
| Product codes | OOX |
| Device names | OOX - Automated Occult Blood Analyzer |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.6550 |
| Review panels | Hematology |
| Registered establishments | EIKEN CHEMICAL CO., LTD., Eiken Chemical Co., Ltd. Nasu Plant, EIKEN CHEMICAL CO., LTD. NOGI PLANT, Nanbu Plastics Co., Ltd. Fujieda Factory |
| Establishment registrations | 9611917, 3005610352, 3007114058, 3010391795 |
| FEI numbers | 3002806884, 3007114058, 3009431614, 3010391795 |
| Establishment operations | Contract Manufacturer, Manufacturer, Specification Developer |
| 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