K221693 is an FDA 510(k) clearance for the Elecsys Anti-HCV II (08837031190). This device is classified as a Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (Class II - Special Controls, product code MZO).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 4, 2023, 208 days after receiving the submission on June 10, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3169.
| 510(k) Number | K221693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2022 |
| Decision Date | January 04, 2023 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MZO — Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3169 |