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FDA 510(k)

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

K-Number: K171498 · 2018-01-12

ApplicantMeso Scale Diagnostics, LLC
Decision Date2018-01-12
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is a medical device manufactured by Meso Scale Diagnostics, LLC. It received FDA 510(k) clearance on 2018-01-12 under approval number K171498. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is a medical device that received FDA 510(k) clearance on 2018-01-12. It is manufactured by Meso Scale Diagnostics, LLC. The 510(k) number is K171498.

When was MSD CRP Assay Kit and MESO SECTOR S 700 Instrument approved by the FDA?

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument received FDA 510(k) clearance on 2018-01-12, under approval number K171498.

What company makes MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is manufactured by Meso Scale Diagnostics, LLC.

What is the FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

The FDA product code for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument is DCN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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