Cleared Traditional

LIAISON MeMed BV, LIAISON MeMed BV Control Set

K213936 · DiaSorin, Inc. · Microbiology
Jul 2022
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K213936 is an FDA 510(k) clearance for the LIAISON MeMed BV, LIAISON MeMed BV Control Set, a Immunoassay For Host Biomarkers Of Infection (Class II — Special Controls, product code QPS), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on July 14, 2022, 210 days after receiving the submission on December 16, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K213936 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2021
Decision Date July 14, 2022
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QPS — Immunoassay For Host Biomarkers Of Infection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens.