QUS-2 (TM) CALCANEAL ULTRASONOMETER
FDA premarket approval P990039 · decided 2000-08-01
Approval details
- PMA number
- P990039
- Trade name
- QUS-2 (TM) CALCANEAL ULTRASONOMETER
- Generic name
- Tester, acoustic, bone quality
- Applicant
- Quidel Corp.
- Date received
- 1999-07-14
- Decision date
- 2000-08-01
- Days to decision
- 384 days
- Decision code
- APWD
- Product code
- NAN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- APPROVAL FOR THE QUS-2 CALCANEAL ULTRASONOMETER. THE QUS-2 ULTRASONOMETER IS A MEDICAL DEVICE THAT UTILIZES QUANTITATIVE ULTRASOUND FOR EVALUATION OF THE CALCANEUS. ITS BUA (BROADBAND ULTRASOUND ATTENUATION) VALUE IS INTENDED TO BE USED AS AN AID IN THE DIAGNOSIS OF OSTEOPOROSIS AND IN THE DETERMINATION OF RISK OF SUBSEQUENT ATRAUMATIC FRACTURE.
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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 |