K771378

Substantially Equivalent

NEO TSH-RIA KIT

Applicant: Nuclear Medical Systems, Inc.
Product code: JLW
Advisory panel: Clinical Chemistry
Date received: 1977-07-20
Decision date: 1977-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, 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.