QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
FDA 510(k) clearance K945080 · decided 1995-02-10
Clearance details
- K-number
- K945080
- Device name
- QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
- Applicant
- Quidel Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-17
- Decision date
- 1995-02-10
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- GTY
- Device class
- 1
- Regulation number
- 866.3740
- 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.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectio recall (Z-1598-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
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 |