K904666

Substantially Equivalent

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

Applicant: Amersham Corp.
Product code: JLW
Advisory panel: Clinical Chemistry
Date received: 1990-10-15
Decision date: 1990-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington Heights, IL, US

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.