PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
FDA 510(k) clearance K071511 · decided 2007-10-05
Clearance details
- K-number
- K071511
- Device name
- PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
- Applicant
- Focus Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-04
- Decision date
- 2007-10-05
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- MXJ
- Device class
- 2
- Regulation number
- 866.3305
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.