K870268

Substantially Equivalent

DIAGNOSTIC KIT FREE T3 AND FREE T4

Applicant: Sclavo, Inc.
Product code: CEC
Advisory panel: Clinical Chemistry
Date received: 1987-01-23
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayne, NJ, 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.