NUCLISENS EASYQ ENTEROVIRUS SYSTEM— 510(k) K063261
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K063261 for NUCLISENS EASYQ ENTEROVIRUS SYSTEM, Substantially Equivalent on 2008-06-23. Applicant: bioMerieux, Inc.. Device class: 2.
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Code OAI
- Device class
- Class 2
- Regulation
- 21 CFR 866.3225
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Durham, NC, US
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