BIOCIRCUITS IOS (IN-OFFICE SYSTEM)— 510(k) K952719

Substantially Equivalent

Biocircuits Corp.

FDA 510(k) clearance K952719 for BIOCIRCUITS IOS (IN-OFFICE SYSTEM), Substantially Equivalent on 1995-11-22. Applicant: Biocircuits Corp..

Clearance details

Applicant: Biocircuits Corp.
Product code: Code KHO
Advisory panel: Clinical Chemistry
Date received: 1995-06-15
Decision date: 1995-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.