Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack— 510(k) K202755
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K202755 for Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack, Substantially Equivalent on 2022-11-05. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code QDZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3181
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code QDZ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.