FDA device listing
ALINITY HQ ANALYZER (09P68-01),Alinity hq (LN 09P68-02),Alinity hs (09P69-02),ALINITY HS SLIDE MAKER STAINER MODULE…
FDA device listing 1095503250 · ABBOTT LABORATORIES
Key facts
| Proprietary names | ALINITY HQ ANALYZER (09P68-01),Alinity hq (LN 09P68-02),Alinity hs (09P69-02),ALINITY HS SLIDE MAKER STAINER MODULE (09P69-01) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K243283 |
| Product codes | GKZ, KPA |
| Device names | GKZ - Counter, Differential Cell, KPA - Slide Stainer, Automated |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 864.3800, 864.5220 |
| Review panels | Hematology, Pathology |
| Registered establishments | ABBOTT LABORATORIES, Abbott Laboratories (Singapore) Private Limited |
| Establishment registrations | 3005333358, 3006412379, 3016438761 |
| FEI numbers | 3005333358, 3006412379, 3016438761 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None 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