IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
FDA premarket approval P930027 · decided 1995-09-15
Approval details
- PMA number
- P930027
- Trade name
- IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 1993-08-10
- Decision date
- 1995-09-15
- Days to decision
- 766 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- APPROVAL FOR THE COAT-A-COUNT PSA IRMA
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