DeviceClearance

UniCel DxH 900 Coulter Cellular Analysis System +2 more— 510(k) K240252

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K240252 for UniCel DxH 900 Coulter Cellular Analysis System +2 more, Substantially Equivalent on 2024-07-05. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Device name as filed
UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
Applicant
Beckman Coulter, Inc.
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
Download summary PDFView on FDA.gov ↗

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More clearances from Beckman Coulter, Inc.

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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 K240252

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K240252.

Data sourced from openFDA. This site is unofficial and independent of the FDA.