Sofia 2 Campylobacter FIA— 510(k) K211342
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K211342 for Sofia 2 Campylobacter FIA, Substantially Equivalent on 2021-11-23. Applicant: Quidel Corporation. Device class: 1.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code LQP
- Device class
- Class 1
- Regulation
- 21 CFR 866.3110
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.