PMA P970038S001
- Device
- TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S001
- Product code
- MTG
- Decision date
- 1998-09-24
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- Approval for changes to the patient labeling.
Current openFDA PMA Record#
- Device
- TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S001
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 1998-09-24
- Decision code
- APPR
- Date received
- 1998-07-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the patient labeling.