DeviceClearance

Product code DHA— Clinical Chemistry

ABBOTT ARCHEITECT TOTAL B-HCG

Classification name
System, Test, Human Chorionic Gonadotropin
Device class
Class 2
Regulation
21 CFR 862.1155
Advisory panel
Clinical Chemistry
Total cleared
72
First cleared
Most recent

Market context for product code DHA

FDA has cleared 72 devices under product code DHA between 1986 and 2024, filed by 51 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DHA

Adverse events under product code DHA

product code DHA
Malfunction
1,242
Total
1,242

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DHA

Data sourced from openFDA. This site is unofficial and independent of the FDA.