FDA 510(k)

MSD CRP Assay Kit and MESO SECTOR S 700 Instrument

K-Nummer: K171498 · 2018-01-12

AntragstellerMeso Scale Diagnostics, LLC

Entscheidungsdatum2018-01-12

ProduktcodeDCN

BeratungsausschussIM

EntscheidungSubstantially Equivalent

Produktübersicht

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

Häufig gestellte Fragen

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. The listed applicant is Meso Scale Diagnostics, LLC. The 510(k) number is K171498.

When did MSD CRP Assay Kit and MESO SECTOR S 700 Instrument receive FDA 510(k) clearance?

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

Who is the listed applicant for MSD CRP Assay Kit and MESO SECTOR S 700 Instrument?

The FDA 510(k) record lists Meso Scale Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Verwandte Geräte (Code: DCN)

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K161982C-Reactive Protein Kit for use on SPAPLUSThe Binding Site Group

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.