OSOM INFLUENZA A&B TEST MODEL 190— 510(k) K123182
Substantially EquivalentSEKISUI Diagnostics, LLC
FDA 510(k) clearance K123182 for OSOM INFLUENZA A&B TEST MODEL 190, Substantially Equivalent on 2012-11-05. Applicant: SEKISUI Diagnostics, LLC. Device class: 1.
Clearance details
- Applicant
- SEKISUI Diagnostics, LLC
- Product code
- Code GNX
- Device class
- Class 1
- Regulation
- 21 CFR 866.3330
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.