PMA P130017S002
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S002
- Product code
- PHP
- Decision date
- 2015-08-18
- Classification
- System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.
Current openFDA PMA Record#
- Device
- COLOGUARD
- Applicant
- Exact Sciences Corporation
- PMA number
- P130017
- Supplement
- S002
- Product code
- PHP
- Generic name
- System, colorectal neoplasia, DNA methylation and hemoglobin detection
- Decision date
- 2015-08-18
- Decision code
- APPR
- Date received
- 2015-05-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO EXTEND THE SHELF LIFE OF THE COLOGUARD ASSAY REAGENTS(COLOGUARD MOLECULAR ASSAY REAGENTS, COLOGUARD MOLECULAR CONTROLS, COLOGUARD HEMOGLOBIN ASSAY REAGENTS, AND COLOGUARD HEMOGLOBIN CONTROLS), ON THE BASIS OF ADDITIONAL REAL-TIME STABILITY TESTING, FROM A SHELF-LIFE OF SIX (6) MONTHS TO A SHELF-LIFE OF NINE (9) MONTHS.