QUS-2 CALCANEAL ULTRASONOMETER
FDA premarket approval P990039/S001 · decided 2003-06-19
Approval details
- PMA number
- P990039
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- QUS-2 CALCANEAL ULTRASONOMETER
- Generic name
- Tester, acoustic, bone quality
- Applicant
- Quidel Corp.
- Date received
- 2003-04-14
- Decision date
- 2003-06-19
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- NAN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR A NEW MANUFACTURING FACILITY LOCATED AT PLEXUS EA, SEATTLE, BOTHELL, WA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K131813) | Quidel Corp. | 2013-09-06 |
| QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K131728) | Quidel Corp. | 2013-08-29 |
| SOFIA(R) RSV FIA (K130398) | Quidel Corp. | 2013-08-13 |
| SOFIA(R) HCG FIA (K131166) | Quidel Corp. | 2013-08-02 |
| SOFIA INFLUENZA A+B FIA (K131606) | Quidel Corp. | 2013-07-05 |
| QUICKVUE INFLUENZA A+B (K131619) | Quidel Corp. | 2013-06-28 |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K122189) | Quidel Corp. | 2013-03-08 |
| QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY (K123998) | Quidel Corp. | 2013-03-08 |