Cleared Traditional

Elecsys Anti-HAV II

K190428 · Roche Diagnostics · Microbiology
Aug 2019
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K190428 is an FDA 510(k) clearance for the Elecsys Anti-HAV II, a Hepatitis A Test (antibody And Igm Antibody) (Class II — Special Controls, product code LOL), submitted by Roche Diagnostics (Indianpolis, US). The FDA issued a Cleared decision on August 13, 2019, 172 days after receiving the submission on February 22, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K190428 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2019
Decision Date August 13, 2019
Days to Decision 172 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LOL — Hepatitis A Test (antibody And Igm Antibody)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3310