IMMULITE(R) THIRD GENERATION PSA
FDA premarket approval P930027/S001 · decided 1996-07-11
Approval details
- PMA number
- P930027
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMULITE(R) THIRD GENERATION PSA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 1995-10-18
- Decision date
- 1996-07-11
- Days to decision
- 267 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Gwynedd Ll55 4el
- Statement
- APPROVAL FOR CHANGING THE COAT-A-COUNT PSA IRMA FROM AN IMMUNORADIOMETRIC TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF PROSTATE SPECIFIC ANTIGEN IN HUMAN SERUM TO A SOLID PHASE, TWO-SITE CHEMILUMINESCENT IMMUNOMETRIC ASSAY FOR USE ON THE IMMULITE AUTMOATED IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME IMMULITE PSA
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