FDA 510(k), K221007, cobas HCV

510(K) Number: K221007
Device Name: cobas HCV
Manufacturer: Roche Molecular Systems, Inc.
Device Classification Name: Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
Regulation Number: 866.3170
Classification Product Code: MZP
Date Received: 04/05/2022
Decision Date: 11/04/2022
Regulation Medical Specialty: Microbiology

668 pages (4,314 of 4,982 pages are fully redacted)