Semen Analysis Device

POV · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220

Classification

FDA Product Code: POV
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.5220
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

Device used to evaluate one or more human semen parameters including semen volume, sperm concentration, total sperm number, sperm motility, sperm morphology, sperm vitality, white blood cell concentration, and pH.

Market data

Cleared 510(k) submissions: 28
Registered establishments: 13

Source

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