ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS
FDA premarket approval P990055/S006 · decided 2003-05-09
Approval details
- PMA number
- P990055
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS
- Generic name
- ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2003-04-21
- Decision date
- 2003-05-09
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- NAF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- East Walpole, MA
- Statement
- APPROVAL FOR LABELING CHANGES TO THE ACS: 180 AND ADVIA CENTAUR COMPLEXED PSA (CPSA) IMMUNOASSAYS.
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