510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210011Unknown

Invitae Common Hereditary Cancers Panel

Invitae Corporation, San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210011 is the FDA 510(k) clearance record for Invitae Common Hereditary Cancers Panel, a class II device, cleared for Invitae Corporation on under FDA product code QVU (High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.). FDA's definition for product code QVU reads: "A high throughput DNA sequencing for hereditary cancer predisposition assessment test system is a qualitative in vitro diagnostic (IVD) system intended for analysis of human DNA extracted from human specimens to detect germline mutations...". FDA records list one 510(k) clearance for Invitae Corporation. As of , FDA records show no recalls naming DEN210011.

Clearance record

Decision date
Received
(914 days to decision)
Product code
QVU High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
Regulation
21 CFR 866.6095
Device class
Class II
Review panel
Pathology
Applicant
Invitae Corporation 1400 16th St., San Francisco CA
Third party review
No

Clearances, product code QVU

Trailing 12 months

FDA records hold no clearances under product code QVU in the trailing twelve months.

FDA records show no clearances under product code QVU in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QVU, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260