FLUOROMATIC ANALYZER AND AUTOSAMPLER— 510(k) K791329

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K791329 for FLUOROMATIC ANALYZER AND AUTOSAMPLER, Substantially Equivalent on 1979-07-30. Applicant: Bio-Rad.

Clearance details

Applicant: Bio-Rad
Product code: Code KHO
Advisory panel: Clinical Chemistry
Date received: 1979-07-18
Decision date: 1979-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

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.