510(k) K221693
K221693 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys Anti-HCV II (08837031190)". The FDA issued a decision of Substantially Equivalent on January 4, 2023. The device falls under product code MZO (Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus), a Class II device regulated under 21 CFR 866.3169. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2023
- Date Received
- June 10, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- Device Class
- Class II
- Regulation Number
- 866.3169
- Review Panel
- MI
- Submission Type