PMA P990039S001
- Device
- QUS-2 CALCANEAL ULTRASONOMETER
- Applicant
- Quidel Corp.
- PMA number
- P990039
- Supplement
- S001
- Product code
- NAN
- Decision date
- 2003-06-19
- Classification
- Tester, Acoustic, Bone Quality
- Generic name
- Tester, acoustic, bone quality
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.
Current openFDA PMA Record#
- Device
- QUS-2 CALCANEAL ULTRASONOMETER
- Applicant
- Quidel Corp.
- PMA number
- P990039
- Supplement
- S001
- Product code
- NAN
- Generic name
- Tester, acoustic, bone quality
- Decision date
- 2003-06-19
- Decision code
- APPR
- Date received
- 2003-04-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.