FDA Product Code MZO: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Leading manufacturers include Abbott Laboratories and Roche Diagnostics.
3
Total
3
Cleared
189d
Avg days
2023
Since
Growing category -
2 submissions in the last 2 years
vs 1 in the prior period
Consistent review times:
180d avg (recent)
FDA 510(k) Cleared Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus Devices (Product Code MZO)
3 devices
Cleared
Sep 23, 2026
Anti-HCV Next
Abbott Laboratories
Microbiology
89d
Cleared
Apr 28, 2026
Anti-HCV Next
Abbott Laboratories
Microbiology
270d
Cleared
Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
Roche Diagnostics
Microbiology
208d
About Product Code MZO - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code MZO since 2023, with 3 receiving FDA clearance (average review time: 189 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MZO Product Code
FDA review times for MZO submissions have been consistent, averaging 180 days recently vs 208 days historically.
MZO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →