ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA)
FDA premarket approval P950021/S008 · decided 2006-11-06
Approval details
- PMA number
- P950021
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADVIA IMS COMPLEXED PROSTATE SPECIFIC ANTIGEN ASSAY (CPSA)
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2006-05-17
- Decision date
- 2006-11-06
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE LOCATED AT FISHER DIAGNOSTICS, MIDDLETOWN, VIRGINIA.
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