Home › Device types › KRY
Calibrator For Platelet Counting
FDA product code KRY · Class 2 · Hematology
10
Registered devices
7
Adverse events
1
Recalls
8
510(k) clearances
Devices with this code
Cal-Chex A Plus — STRECK, INC.Cal-Chex A Plus — STRECK, INC.COULTER S-CAL — Beckman Coulter, Inc.Atellica HEMA Calibrator — Siemens Healthcare Diagnostics Inc.CDS-LTX PRIMER — CLINICAL DIAGNOSTIC SOLUTIONS, INC.CELL-DYN — ABBOTT LABORATORIESCOULTER S-CAL — Beckman Coulter, Inc.Cal-Chex A Plus — STRECK, INC.COULTER S-CAL — Beckman Coulter, Inc.Alinity — Abbott GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-09-18 | Abbott Laboratories | Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.