FDA device listing
Calibrator For Platelet Counting
FDA device listing 1423189500 · Boule Diagnostics AB
Key facts
| Owner/operator | Boule Diagnostics AB |
|---|---|
| Owner/operator number | 9034165 |
| Premarket submissions | K041130 |
| Product codes | KRY, KRZ, KSA |
| Device names | 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) | 864.8165, 864.8175, 864.8185 |
| Review panels | Hematology |
| Registered establishments | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
| Establishment registrations | 1064130 |
| FEI numbers | 3002684533 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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