Cleared Traditional

MeMed BV

K210254 · MeMed Diagnostics, Ltd. · Microbiology
Sep 2021
Decision
215d
Days
Class 2
Risk

About This 510(k) Submission

K210254 is an FDA 510(k) clearance for the MeMed BV, a Immunoassay For Host Biomarkers Of Infection (Class II — Special Controls, product code QPS), submitted by MeMed Diagnostics, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on September 1, 2021, 215 days after receiving the submission on January 29, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number K210254 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2021
Decision Date September 01, 2021
Days to Decision 215 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.