Cleared Traditional

Elecsys Anti-HCV II (08837031190)

K221693 · Roche Diagnostics · Microbiology

Jan 2023

Decision

208d

Days

Class 2

Risk

About This 510(k) Submission

K221693 is an FDA 510(k) clearance for the Elecsys Anti-HCV II (08837031190), a Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (Class II — Special Controls, product code MZO), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on January 4, 2023, 208 days after receiving the submission on June 10, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3169.

Submission Details

510(k) Number	K221693 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 10, 2022
Decision Date	January 04, 2023
Days to Decision	208 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF