P2psa

OYA · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: OYA
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: IM
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Quantitative determination of [-2]proPSA antigen in human serum to be used in combination with total PSA and free PSA to calculate the Prostate Health Index (phi)

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

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