MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
FDA 510(k) clearance K111527 · decided 2011-08-03
Clearance details
- K-number
- K111527
- Device name
- MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
- Applicant
- Eragen Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-01
- Decision date
- 2011-08-03
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- OQO
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| artus HSV-1/2 QS-RGQ MDx Kit (K142738) | Qiagen | 2014-12-19 |
| IMDX HSV-1/2 FOR ABBOTT M2000 (K140198) | Intelligent Medical Devices, Inc. | 2014-05-13 |
| AMIPLIVUE HSV 1&2 ASSAY (K140029) | Quidel Corporation | 2014-03-26 |
| ISOAMP HSV ASSAY (K111951) | Biohelix Corporation | 2011-09-27 |
| BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (K103798) | Becton, Dickinson & CO | 2011-03-18 |
| MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 (K100336) | Eragen Biosciences | 2010-05-12 |
Recalls involving this device
No recalls on record reference this clearance.