ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002— 510(k) K060215

Substantially Equivalent

Eurotrol B.V.

FDA 510(k) clearance K060215 for ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002, Substantially Equivalent on 2006-03-24. Applicant: Eurotrol B.V..

Clearance details

Applicant: Eurotrol B.V.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2006-01-27
Decision date: 2006-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.