IMMUNOASAY, PSA
FDA premarket approval P910065/S008 · decided 2012-02-13
Approval details
- PMA number
- P910065
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- IMMUNOASAY, PSA
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 2011-03-30
- Decision date
- 2012-02-13
- Days to decision
- 320 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- APPROVAL FOR THE ADDITION OF ONE FDA-CLEARED TOSOH AUTOMATED IMMUNOASSAY ANALYZER, THE AIA-900, FOR USE WITH THE ST AIA-PACK PA ASSAY.
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