PENTRA XLR— 510(k) K151133

Substantially Equivalent

HORIBA ABX SAS

FDA 510(k) clearance K151133 for PENTRA XLR, Substantially Equivalent on 2015-12-09. Applicant: HORIBA ABX SAS.

Clearance details

Applicant: HORIBA ABX SAS
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2015-04-28
Decision date: 2015-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montpellier, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GKZ

product code GKZ

Malfunction: 1,205
Total: 1,205

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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