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Invitae Common Hereditary Cancers Panel

DEN210011 Class II Direct
Decision Date
2023-09-29
Sponsor / Applicant
Invitae Corporation

Technical Specification

510(k) Submission ID DEN210011
Product Code QVU
Medical Specialty / Panel Pathology
Regulation Citation 21 CFR 866.6095
Decision Date 2023-09-29
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

Invitae Common Hereditary Cancers Panel received FDA 510(k) clearance under submission number DEN210011, sponsored by Invitae Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2023-09-29.

Classification & Regulation

This clearance is catalogued under FDA product code QVU and 21 CFR 866.6095, within the Pathology review panel as a Class II device.