Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack— 510(k) K163085
Substantially EquivalentFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
FDA 510(k) clearance K163085 for Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack, Substantially Equivalent on 2017-02-14. Applicant: Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Focus Diagnostics, Inc.:Dba Diasorin Molecular, LLC
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.