Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack— 510(k) K173498
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K173498 for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack, Substantially Equivalent on 2018-08-13. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code OZZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- 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.