XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
FDA 510(k) clearance K120911 · decided 2012-05-18
Clearance details
- K-number
- K120911
- Device name
- XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2012-03-26
- Decision date
- 2012-05-18
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- OQW
- Device class
- 2
- Regulation number
- 866.3332
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sunnyvale, CA, US
- 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 |
|---|---|---|
| PRODESSE PROFAST+ ASSAY (K132237) | Gen-Probe Prodesse, Inc. | 2013-08-26 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K130551) | Centers for Disease Control and Prevention | 2013-05-22 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K123905) | Centers for Disease Control and Prevention | 2013-01-14 |
| JBAIDS INFLUENZA A SUBTYPING KIT (K111778) | U.S Army Medical Materiel Development Activity | 2011-09-13 |
| CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K111507) | Centers for Disease Control and Prevention | 2011-08-23 |
| XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 (K103766) | Cepheid | 2011-04-21 |
| PROFAST+ ASSAY (K101855) | Gen-Probe Prodesse, Inc. | 2010-07-23 |
| CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL (K101564) | Centers for Disease Control and Prevention | 2010-06-22 |
| SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 (K100148) | Focus Diagnostics, Inc. | 2010-05-24 |
Recalls involving this device
No recalls on record reference this clearance.