QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
FDA 510(k) clearance K061008 · decided 2006-09-08
Clearance details
- K-number
- K061008
- Device name
- QUICKVUE RSV (20 TEST KIT), MODEL 20193; (2 TEST KIT), MODEL 20199
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-12
- Decision date
- 2006-09-08
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- MCE
- Device class
- 1
- Regulation number
- 866.3480
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Quidel Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KALLESTAD RSV MICROPLATE EIA (K924289) | Bio-Rad Laboratories, Inc. | 1993-02-12 |
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 |