PENTRA 80— 510(k) K024002

Name: FDA 510(k) clearance K024002
Creator: U.S. Food and Drug Administration
Published: 2003-01-03

Substantially Equivalent

Abx Diagnostics

FDA 510(k) clearance K024002 for PENTRA 80, Substantially Equivalent on 2003-01-03. Applicant: Abx Diagnostics. Device class: 2.

Clearance details

Applicant: Abx Diagnostics
Product code: Code GKZ
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2002-12-04
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Montpellier, FR

Download summary PDF View on FDA.gov ↗

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K030799 — MICROS 602003-04-08
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K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 1202002-07-29
K014203 — ABX MICROS 60 HEMATOLOGY ANALYZER2002-02-28
K003677 — ABX PENTRA 60C+ HEMATOLOGY ANALYZER2000-12-26

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.