510(k) Report

FDA applicant

Invitae Corporation

San Francisco, CA1 decision2023–20230 recalls

FDA records 1 decision for Invitae Corporation (San Francisco, CA) in 2023: 1 De Novo grant. All are in product code QVU (High Throughput Dna Sequencing For Hereditary…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Invitae Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Invitae Corporation by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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