Cleared Traditional

Maverick RNP Assay and Maverick Diagnostic System

K191085 · Genalyte, Inc. · Immunology

Oct 2019

Decision

184d

Days

Class 2

Risk

About This 510(k) Submission

K191085 is an FDA 510(k) clearance for the Maverick RNP Assay and Maverick Diagnostic System, a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Genalyte, Inc. (San Diego, US). The FDA issued a Cleared decision on October 25, 2019, 184 days after receiving the submission on April 24, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K191085 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2019
Decision Date	October 25, 2019
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement