BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS— 510(k) K961566

Substantially Equivalent

Biocircuits Corp.

FDA 510(k) clearance K961566 for BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS, Substantially Equivalent on 1996-11-18. Applicant: Biocircuits Corp..

Clearance details

Applicant: Biocircuits Corp.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1996-04-23
Decision date: 1996-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.