AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer— 510(k) K170232

Substantially Equivalent

Boditech Med, Inc.

FDA 510(k) clearance K170232 for AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer, Substantially Equivalent on 2017-10-13. Applicant: Boditech Med, Inc..

Clearance details

Applicant: Boditech Med, Inc.
Product code: 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

Download summary PDF View on FDA.gov ↗

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.