meddevicedb.com FDA Device Reference

Cell-Free DNA BCT

DEN200001 Class II Direct
Decision Date
2020-08-07
Sponsor / Applicant
Streck, Inc.

Technical Specification

510(k) Submission ID DEN200001
Product Code QMA
Medical Specialty / Panel Clinical Chemistry
Regulation Citation 21 CFR 862.1676
Decision Date 2020-08-07
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Cell-Free DNA BCT received FDA 510(k) clearance under submission number DEN200001, sponsored by Streck, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2020-08-07.

Classification & Regulation

This clearance is catalogued under FDA product code QMA and 21 CFR 862.1676, within the Clinical Chemistry review panel as a Class II device.