K912937

Substantially Equivalent

SR1 FREE T4 ENZYME IMMUNOASSAY

Applicant: Serono-Baker Diagnostics, Inc.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1991-07-05
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, 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.