QbCheck
FDA 510(k) clearance K143468 · decided 2016-03-22
Clearance details
- K-number
- K143468
- Device name
- QbCheck
- Applicant
- Qbtech AB
- Decision
- Substantially Equivalent
- Date received
- 2014-12-04
- Decision date
- 2016-03-22
- Days to decision
- 474 days
- Clearance type
- Traditional
- Product code
- LQD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Stockholm, SE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Test of Variables of Attention (T.O.V.A.) (K173915) | The Tova Company | 2018-03-22 |
| Test of Variables of Attention (T.O.V.A.) Version 9.0 (K170082) | The Tova Company | 2017-05-17 |
| DANA (K141865) | Anthrotronix, Inc. | 2014-10-15 |
| QB TEST (K133382) | Qbtech AB | 2014-03-24 |
| QBTES (K122149) | Qbtech AB | 2012-10-17 |
| QBTEST (K040894) | Qbtech AB | 2004-06-22 |
| OPTAX SYSTEM (K020800) | Optax Systems, Inc. | 2002-06-10 |
| DYNAVISION 2000 (K911938) | Performance Ent. | 1991-08-02 |
| FAGAN TEST MACHINE FOR INFANT INTELLIGENCE (K861304) | Infantest Corp. | 1986-09-23 |
| GORDON DIAGNOSTIC SYSTEM MODEL I (K854903) | Clinical Diagnostics, Inc. | 1986-06-02 |
Recalls involving this device
No recalls on record reference this clearance.