CHEMPAQ XBC ANALYZER— 510(k) K090013

Substantially Equivalent

Chempaq A/S

FDA 510(k) clearance K090013 for CHEMPAQ XBC ANALYZER, Substantially Equivalent on 2009-04-21. Applicant: Chempaq A/S.

Clearance details

Applicant: Chempaq A/S
Product code: Code GKZ
Advisory panel: Hematology
Date received: 2009-01-02
Decision date: 2009-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Farum, DK

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.