PMA P970058
- Device
- IMAGE CHECKER, IMAGE CHECKER LICENSE
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S027
- Product code
- MYN
- Decision date
- 2016-04-26
- Generic name
- Analyzer, medical image
- Approval order statement
- Approval for a manufacturing site located at 36 Apple Ridge Road, Danbury, CT.
Current openFDA PMA Record#
- Device
- IMAGE CHECKER, IMAGE CHECKER LICENSE
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S027
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 2016-04-26
- Decision code
- APPR
- Date received
- 2016-01-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at 36 Apple Ridge Road, Danbury, CT.