Circulating Tumor Cell (Ctc) Enrichment Device

QSA · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6110

Classification

FDA Product Code: QSA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.6110
Review panel: PA
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown