Elecsys Anti-HCV II (08837031190)
FDA 510(k) clearance K221693 · decided 2023-01-04
Clearance details
- K-number
- K221693
- Device name
- Elecsys Anti-HCV II (08837031190)
- Applicant
- Roche Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2022-06-10
- Decision date
- 2023-01-04
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- MZO
- Device class
- 2
- Regulation number
- 866.3169
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Anti-HCV Next (K252424) | Abbott Laboratories | 2026-04-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S007) | Roche Diagnostics | 2025-05-22 |
| Elecsys Anti-HBe (P190005/S006) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs / Elecsys HBs II (P190034/S009) | Roche Diagnostics | 2024-10-03 |
| Elecsys Anti-HBs II (P190034/S008) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBe (P190005/S005) | Roche Diagnostics | 2024-08-29 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005) | Roche Diagnostics | 2024-05-01 |