K170232

Substantially Equivalent

AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer

Applicant: Boditech Med, Inc.
Product code: JLW
Advisory panel: Clinical Chemistry
Date received: 2017-01-25
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuncheon-Si, KR

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.