Cleared Traditional

HAVAb IgG II

K222850 · Abbott Laboratories · Microbiology
Aug 2023
Decision
323d
Days
Class 2
Risk

About This 510(k) Submission

K222850 is an FDA 510(k) clearance for the HAVAb IgG II, a Hepatitis A Test (antibody And Igm Antibody) (Class II — Special Controls, product code LOL), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 10, 2023, 323 days after receiving the submission on September 21, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3310.

Submission Details

510(k) Number K222850 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2022
Decision Date August 10, 2023
Days to Decision 323 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