ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS
FDA premarket approval P950021/S003 · decided 2001-08-06
Approval details
- PMA number
- P950021
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ACS:180 AND ADVIA CENTAUR PSA IMMUNOASSAYS
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2000-09-28
- Decision date
- 2001-08-06
- Days to decision
- 312 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR PROCESSING AND FINAL PACKAGING AT BAYER DIAGNOSTICS, WALPOLE, MASSACHUSETTS.
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