Cleared Traditional

Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

K234091 · Genalyte, Inc. · Chemistry

Jul 2024

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K234091 is an FDA 510(k) clearance for the Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Genalyte, Inc. (San Diego, US). The FDA issued a Cleared decision on July 22, 2024, 209 days after receiving the submission on December 26, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number	K234091 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2023
Decision Date	July 22, 2024
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement