ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
FDA premarket approval P950021 · decided 1995-12-22
Approval details
- PMA number
- P950021
- Trade name
- ADVIA CENTAUR & ADVIA CENTAUR CP PSA IMMUNOASSAY
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 1995-06-27
- Decision date
- 1995-12-22
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR THE TECHNICON IMMUNO 1 PSA ASSAY - THIS DEVICE IS AN IN VITRO DIAGNOSTIC DEVICE
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