DHA

System, Test, Human Chorionic Gonadotropin

Product code
DHA
Device name
System, Test, Human Chorionic Gonadotropin
Device class
Class 2
21 CFR
21 CFR 862.1155
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
72 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-05-08.

NumberDecision dateApplicantDevice nameSummary
K2335812024-05-08Ortho Clinical DiagnosticsVITROS Immunodiagnostic Products Total ß-hCG II Reag…PDF
K2236902023-12-11Shenzhen Yhlo Biotech Co., Ltd.iFlash-HCG; Chemiluminescence Immunoassay Analyzer (…PDF

2 summaries are archived here for direct download.

Official FDA classification page: DHA
Classification and pathway per current FDA publications. Data from openFDA (CC0).