QUICKVUE ADVANCE PH AND AMINES GLL TEST
FDA 510(k) clearance K040008 · decided 2004-04-29
Clearance details
- K-number
- K040008
- Device name
- QUICKVUE ADVANCE PH AND AMINES GLL TEST
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-02
- Decision date
- 2004-04-29
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- CEN
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| QUS-2 CALCANEAL ULTRASONOMETER (P990039/S001) | Quidel Corp. | 2003-06-19 |
| QUS-2 (TM) CALCANEAL ULTRASONOMETER (P990039) | Quidel Corp. | 2000-08-01 |