Automated Occult Blood Analyzer

OOX · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.6550

Classification

FDA Product Code: OOX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.6550
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 16

Source

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