PMA P970038S014
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S014
- Product code
- MTG
- Decision date
- 2011-02-04
- Classification
- Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S014
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2011-02-04
- Decision code
- APPR
- Date received
- 2011-01-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE FOLLOWING CHANGES: 1) MODIFY THE FLUIDICS INTERCONNECT PANELS TO ADD TUBE CLIPS; 2) ADDITIONAL TUBING LABELS WHICH CORRESPOND WITH FLUIDIC INTERCONNECT PANEL; 3) ADD STRAIN RELIEF AS A BEND DETERRENT; AND 4) UPDATE MAINTENANCE DOCUMENTATION TO REFLECT MODIFIED CONFIGURATION.