Tandem-R Psa Immunoradiometric Assay
FDA premarket approval P850048 · Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
PMA numberP850048
Approval
- Applicant
- Beckman Coulter, Inc.
- Received
- July 9, 1985
- Decision date
- February 25, 1986 (APPR)
- Supplements
- 55, latest September 4, 2024
- Product code
- MTF – Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer