PMA P970038S023
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S023
- Product code
- MTG
- Decision date
- 2013-08-20
- 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 UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.
Current openFDA PMA Record#
- Device
- ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- Applicant
- Beckman Coulter, Inc.
- PMA number
- P970038
- Supplement
- S023
- Product code
- MTG
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Decision date
- 2013-08-20
- Decision code
- APPR
- Date received
- 2013-04-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATING THE LABELING OF UNICEL DX1 INSTRUCTIONS FOR USE, OPERATOR'S GUIDE, REFERENCE MANUAL AND ONBOARD SYSTEM HELP. REQUESTED CHANGES TO THE LABELING INCLUDE CHANGING CURRENT CAUTION STATEMENTS TO WARNING STATEMENTS (TO ENHANCE THESAFETY OF THE OPERATOR, AND REMOVING REDUNDANT CAUTION STATEMENTS), ADDING NEW CAUTION STATEMENTS (NOTES FOR PROCEDURE CLARIFICATION), ADDING NEW WARNING STATEMENTS, CHANGING WARNINGTO CAUTION AND RELOCATING EXISTING WARNING/CAUTION STATEMENTS IN ORDER TO ENHANCE THE SAFETY IN THE USE OF THE REAGENTS ON THE UNICEL DXL 800/600 IMMUNOASSAY SYSTEMS AND UNICEL DXC 880I/860I/680I/ 660I SYNCHRON ACCESS INTEGRATED CLINICAL SYSTEMS.