Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
FDA 510(k) clearance K163085 · decided 2017-02-14
Clearance details
- K-number
- K163085
- Device name
- Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack
- Applicant
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-11-03
- Decision date
- 2017-02-14
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.