iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)— 510(k) K223690

Substantially Equivalent

Shenzhen Yhlo Biotech Co., Ltd.

FDA 510(k) clearance K223690 for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C), Substantially Equivalent on 2023-12-11. Applicant: Shenzhen Yhlo Biotech Co., Ltd..

Clearance details

Applicant: Shenzhen Yhlo Biotech Co., Ltd.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 2022-12-09
Decision date: 2023-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.