PMA P850048S016
- Device
- ACCESS(R) HYBRITECH PSA ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S016
- Product code
- LTJ
- Decision date
- 2000-02-24
- 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 addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms.
Current openFDA PMA Record#
- Device
- ACCESS(R) HYBRITECH PSA ASSAY
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P850048
- Supplement
- S016
- Product code
- LTJ
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Decision date
- 2000-02-24
- Decision code
- APPR
- Date received
- 1999-10-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for addition of the Access Hybritech PSA Assay on the Access Immunoassay analyzer to other approved instrument platforms.