MODIFICATION TO PENTRA 60 AND PENTRA 60C+— 510(k) K030144

Substantially Equivalent

Abx Diagnostics

FDA 510(k) clearance K030144 for MODIFICATION TO PENTRA 60 AND PENTRA 60C+, Substantially Equivalent on 2003-01-31. Applicant: Abx Diagnostics.

Clearance details

Applicant: Abx Diagnostics
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2003-01-15
Decision date: 2003-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Montpellier, FR

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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.