AIA PACK PA
FDA premarket approval P910065/S002 · decided 2000-03-03
Approval details
- PMA number
- P910065
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AIA PACK PA
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Tosoh Bioscience, Inc.
- Date received
- 1999-12-16
- Decision date
- 2000-03-03
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- South San Franciso, CA
- Statement
- Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay.
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