Cleared Traditional

MeMed BV

K230944 · MeMed Diagnostics, Ltd. · Microbiology

Jun 2023

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K230944 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 June 30, 2023, 87 days after receiving the submission on April 4, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3215.

Submission Details

510(k) Number	K230944 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 04, 2023
Decision Date	June 30, 2023
Days to Decision	87 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.