MSD CRP Assay Kit and MESO SECTOR S 700 Instrument— 510(k) K171498

Name: FDA 510(k) clearance K171498
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Substantially Equivalent

Meso Scale Diagnostics, LLC

FDA 510(k) clearance K171498 for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument, Substantially Equivalent on 2018-01-12. Applicant: Meso Scale Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Meso Scale Diagnostics, LLC
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2017-05-23
Decision date: 2018-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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