Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF

K-Number: K221842 · 2022-12-07

ApplicantRoche Diagnostics
Decision Date2022-12-07
Product CodeQSE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2022-12-07 under approval number K221842. The device is classified under product code QSE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF?

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF is a medical device that received FDA 510(k) clearance on 2022-12-07. It is manufactured by Roche Diagnostics. The 510(k) number is K221842.

When was Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF approved by the FDA?

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF received FDA 510(k) clearance on 2022-12-07, under approval number K221842.

What company makes Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF?

Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF?

The FDA product code for Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF is QSE.

Other Devices by Roche Diagnostics

DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160910Elecsys Syphilis K153607ROMA Calculation Tool Using Elecsys Assays K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 K152227Elecsys Cortisol II, Cortisol II CalSet

View all 70 devices →

Related Devices (Code: QSE)

DEN200072Lumipulse G ß-Amyloid Ratio (1-42/1-40)Fujirebio Diagnostics,Inc. K231348Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics

Official Source

View on FDA Database →

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

↑