PMA P910065S002
- Device
- AIA PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S002
- Product code
- LTJ
- Decision date
- 2000-03-03
- Classification
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Approval order statement
- Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay.
Current openFDA PMA Record#
- Device
- AIA PACK PA
- Applicant
- Tosoh Bioscience, Inc.
- PMA number
- P910065
- Supplement
- S002
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2000-03-03
- Decision code
- APPR
- Date received
- 1999-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of the AIA 600 II analyzer instrument to the list of approved analyzers using the AIA-Pack PA assay.