FDA Product Code MZO: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Leading manufacturers include Roche Diagnostics and Abbott Laboratories.
FDA 510(k) Cleared Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Devices (Product Code MZO)
About Product Code MZO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code MZO since 2023, with 2 receiving FDA clearance (average review time: 239 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under MZO have taken an average of 270 days to reach a decision - up from 208 days historically. Manufacturers should account for longer review timelines in current project planning.
MZO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →