FDA device listing
Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321),Hemoglobin A1c Calibrators (LN 4P52-01),Hemoglobin A1c…
FDA device listing 1250633905 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity c Hemoglobin A1c Reagent Kit (LN 08P4320, 08P4321),Hemoglobin A1c Calibrators (LN 4P52-01),Hemoglobin A1c Controls (LN 4P52-11),Hemoglobin A1c (LN 4P52-20, 4P52-22) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K140654 |
| Product codes | JIT, JJX, LCP, PDJ |
| Device names | JIT - Calibrator, Secondary, JJX - Single (Specified) Analyte Controls (Assayed And Unassayed), LCP - Assay, Glycosylated Hemoglobin, PDJ - Hemoglobin A1c Test System |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1150, 862.1373, 862.1660, 864.7470 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | ABBOTT GmbH, ABBOTT LABORATORIES |
| Establishment registrations | 3002809144, 3005333358, 3016438761 |
| FEI numbers | 3002809144, 3005333358, 3016438761 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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