510(k) K932912— STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC

Substantially Equivalent

Baxter Diagnostics, Inc.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code CEC
Advisory panel: Clinical Chemistry
Date received: 1993-06-16
Decision date: 1993-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

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.