Cleared Traditional

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

K171498 · Meso Scale Diagnostics, LLC · Immunology

Jan 2018

Decision

234d

Days

Class 2

Risk

About This 510(k) Submission

K171498 is an FDA 510(k) clearance for the MSD CRP Assay Kit and MESO SECTOR S 700 Instrument, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Meso Scale Diagnostics, LLC (Rockville, US). The FDA issued a Cleared decision on January 12, 2018, 234 days after receiving the submission on May 23, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K171498 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2017
Decision Date	January 12, 2018
Days to Decision	234 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF