FDA device listing
Alinity h-series HemCal (LN 04U7302, 06V86-02),CELL-DYN HemCal Plus (LN 08H57-01)
FDA device listing 1780840005 · ABBOTT LABORATORIES
Key facts
| Proprietary names | Alinity h-series HemCal (LN 04U7302, 06V86-02),CELL-DYN HemCal Plus (LN 08H57-01) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K020469 |
| Product codes | KRX, KRY, KRZ, KSA |
| Device names | KRX - Calibrator For Cell Indices, KRY - Calibrator For Platelet Counting, KRZ - Calibrator For Hemoglobin And Hematocrit Measurement, KSA - Calibrator For Red-Cell And White-Cell Counting |
| Device class | Class II |
| Classification regulations (21 CFR) | 864.8150, 864.8165, 864.8175, 864.8185 |
| Review panels | Hematology |
| Registered establishments | ABBOTT LABORATORIES |
| Establishment registrations | 3005333358, 3016438761 |
| FEI numbers | 3005333358, 3016438761 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| 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