510(k) K874622— FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301

Substantially Equivalent

Cyberfluor, Inc.

Clearance details

Applicant: Cyberfluor, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1987-11-10
Decision date: 1987-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario M5t 1x4, CA

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.