510(k) K221007
K221007 is an FDA 510(k) premarket notification submitted by Roche Molecular Systems, Inc. for the device "cobas HCV". The FDA issued a decision of Substantially Equivalent on November 4, 2022. The device falls under product code MZP (Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus), a Class II device regulated under 21 CFR 866.3170. Roche Molecular Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 2022
- Date Received
- April 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- Device Class
- Class II
- Regulation Number
- 866.3170
- Review Panel
- MI
- Submission Type