MZO

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

Product code
MZO
Device name
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Device class
Class 2
21 CFR
21 CFR 866.3169
Medical specialty
Microbiology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-04-28.

NumberDecision dateApplicantDevice nameSummary
K2524242026-04-28Abbott LaboratoriesAnti-HCV NextPDF

1 summaries are archived here for direct download.

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