Panels › Microbiology › Product code MZO · Class 2
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Regulation 866.3169
2510(k)s in 12 months (3 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in MZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 2 | 1 |
| Abbott GmbH | 0 | 2 |
| Diasorin Inc. | 0 | 1 |
| Home Access Health Corp (HAHC) | 0 | 1 |
| OraSure Technologies, Inc. | 0 | 1 |
| ORTHO-CLINICAL DIAGNOSTICS | 0 | 1 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 2026 | K262156 | Anti-HCV Next Abbott Laboratories | MZO |
| Apr 28, 2026 | K252424 | Anti-HCV Next Abbott Laboratories | MZO |
| Jan 4, 2023 | K221693 | Elecsys Anti-HCV II (08837031190) Roche Diagnostics | MZO |
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