Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack— 510(k) K173798
Substantially EquivalentDiasorin Molecular, LLC
FDA 510(k) clearance K173798 for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack, Substantially Equivalent on 2018-03-14. Applicant: Diasorin Molecular, LLC. Device class: 2.
Clearance details
- Applicant
- Diasorin Molecular, LLC
- Product code
- Code PGI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3309
- 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.