TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
FDA premarket approval P970038 · decided 1998-03-10
Approval details
- PMA number
- P970038
- Trade name
- TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Beckman Coulter, Inc.
- Date received
- 1997-08-29
- Decision date
- 1998-03-10
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Brea, CA
- Statement
- Approval for the Tandem(R)-R free PSA assay and Tandem(R)-MP free PSA assay. The Tandem(R)-R free PSA Immunoradiometric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. The Tandem(R)-MP free PSA Immunoenzymetric Assay is an In Vitro device for the quantitative measurement of free prostate specific antigen (free PSA) in human serum. Hybritech's Tandem free PSA assays are intened to beused with Tandem (total) PSa to calculate
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