PMA P970038S016
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S016
- Product code
- MTG
- Decision date
- 2012-04-13
- 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 NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES; 2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS; 4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S016
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2012-04-13
- Decision code
- APPR
- Date received
- 2012-03-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR NEW INFORMATION TO BE ADDED TO THE INSTRUCTIONS FOR USE, THE OPERATORS GUIDE AND THE REFERENCE MANUAL, INCLUDING THE FOLLOWING: 1) ADD INSTRUCTIONS TO THE WEEKLY MAINTENANCE SECTIONS OF THESE DOCUMENTS FOR THE INSPECTION OF THE LIQUID WASTE BOTTLES; 2) CLARIFY PACK MIXING INSTRUCTIONS; 3) ADD TROUBLESHOOTING STEPS; 4) CHANGE CAUTIONS INTO WARNINGS; AND 5) CHANGE NOTES INTO WARNINGS.