FDA device listing
HDLC4, 700T, cobas c 503,HDL-C Gen.4, 200Tests c111,HDL-C Gen.4, 350Tests cobas c,Integra,HDL-C Gen.4, 500Tests cobas…
FDA device listing 1223009414 · Roche Diagnostics Operations Inc.
Key facts
| Proprietary names | HDLC4, 700T, cobas c 503,HDL-C Gen.4, 200Tests c111,HDL-C Gen.4, 350Tests cobas c,Integra,HDL-C Gen.4, 500Tests cobas c701/702,HDL-Cholesterol Gen.4 |
|---|---|
| Owner/operator | Roche Diagnostics Operations Inc. |
| Owner/operator number | 9039767 |
| Premarket submissions | K162593 |
| Product codes | LBS |
| Device names | LBS - Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1475 |
| Review panels | Clinical Chemistry |
| Registered establishments | ROCHE DIAGNOSTICS GMBH |
| Establishment registrations | 9610126 |
| FEI numbers | 3002806559 |
| Establishment operations | Manufacturer |
| 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