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Sangia Total PSA Test

by Opko Diagnostics, LLC

PMA P170037

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 30 Jan 2019

PMA

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP170037 Date30 Jan 2019Approval withdrawnStatusWithdrawn

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Generic Name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
PMA Number
FDA Product Code
MTF
Device Class
Class III
Advisory Committee
Immunology
FDA Decision
APWD Approval withdrawn