Unicel DxH 800 Coulter Cellular Analysis System— 510(k) K193124
Substantially EquivalentBeckman Coulter
FDA 510(k) clearance K193124 for Unicel DxH 800 Coulter Cellular Analysis System, Substantially Equivalent on 2020-04-16. Applicant: Beckman Coulter. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code GKZ
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- K183592 — ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer
- K181599 — Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
- K181475 — DxH 520 Hematology Instrument
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K193124
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193124.
Data sourced from openFDA. This site is unofficial and independent of the FDA.