510(k) K221693
- Device
- Elecsys Anti-HCV II (08837031190)
- Applicant
- Roche Diagnostics
- 510(k) number
- K221693
- Product code
- MZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-04
- Date received
- 2022-06-10
- Regulation
- 866.3169
- Classification name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bin Sun
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3005333358
- 2432235
- 3012963943
- 2250051
- 3002809144
- 9612316
- 8031673
- 2032682
- 3011989923
- 3003297763
- 3008576040
- 3002642396
- 1219913
- 9610240
- 3005529799
- 3007111389
- 9610126
- 2029372
- 3012494290
- 1319681
- 3013557562
- 3000308930
- 3022474803
- 3004142665
Source Documents#
Other 510(k) Records For Product Code MZO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252424 | Anti-HCV Next | Abbott Laboratories | 2026-04-28 |