510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MZOClass II

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

21 CFR 866.3169 / Microbiology
FDA source (opens on fda.gov)

MZO is the FDA product code for Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus, a class II device type, regulated under 21 CFR 866.3169. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
MZO
Device name
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Regulation
21 CFR 866.3169
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
7

Clearances, product code MZO

By decision year
3 clearances under product code MZO with a decision year between 2023 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MZO by decision year
YearClearances
20231
20262

Applicants with the most clearances

Product code MZO
Applicants holding the most 510(k) clearances under product code MZO
ApplicantClearances
Abbott Laboratories1
Abbott Medical1
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order