Cleared Traditional

cobas HCV

K221007 · Roche Molecular Systems, Inc. · Microbiology
Nov 2022
Decision
213d
Days
Class 2
Risk

About This 510(k) Submission

K221007 is an FDA 510(k) clearance for the cobas HCV, a Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus (Class II — Special Controls, product code MZP), submitted by Roche Molecular Systems, Inc. (Pleasanton, US). The FDA issued a Cleared decision on November 4, 2022, 213 days after receiving the submission on April 5, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3170.

Submission Details

510(k) Number K221007 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2022
Decision Date November 04, 2022
Days to Decision 213 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MZP — Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3170