BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS— 510(k) K980819

Substantially Equivalent

Biocircuits Corp.

FDA 510(k) clearance K980819 for BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS, Substantially Equivalent on 1998-04-03. Applicant: Biocircuits Corp..

Clearance details

Applicant: Biocircuits Corp.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1998-03-03
Decision date: 1998-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

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.