UNI-FAST ANALYZER SYSTEM— 510(k) K840129

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K840129 for UNI-FAST ANALYZER SYSTEM, Substantially Equivalent on 1984-03-23. Applicant: Sclavo, Inc..

Clearance details

Applicant: Sclavo, Inc.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1984-01-11
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.