AMPLIVUE C. DIFFICILE ASSAY— 510(k) K123355
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K123355 for AMPLIVUE C. DIFFICILE ASSAY, Substantially Equivalent on 2012-12-13. Applicant: Quidel Corporation. Device class: 2.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code OZN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3130
- 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.