PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120— 510(k) K022200

Substantially Equivalent

Abx Diagnostics

FDA 510(k) clearance K022200 for PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120, Substantially Equivalent on 2002-07-29. Applicant: Abx Diagnostics.

Clearance details

Applicant: Abx Diagnostics
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2002-07-05
Decision date: 2002-07-29
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.