PMA P970058S003
- Device
- IMAGE CHECKER
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S003
- Product code
- MYN
- Decision date
- 1999-02-10
- Generic name
- Analyzer, medical image
- Approval order statement
- Approval for proposed post approval study protocol for the ImageChecker M1000.
Current openFDA PMA Record#
- Device
- IMAGE CHECKER
- Applicant
- Hologic, Inc.
- PMA number
- P970058
- Supplement
- S003
- Product code
- MYN
- Generic name
- Analyzer, medical image
- Decision date
- 1999-02-10
- Decision code
- APPR
- Date received
- 1998-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for proposed post approval study protocol for the ImageChecker M1000.