AMPLIVUE C. DIFFICILE ASSAY
FDA 510(k) clearance K123355 · decided 2012-12-13
Clearance details
- K-number
- K123355
- Device name
- AMPLIVUE C. DIFFICILE ASSAY
- Applicant
- Quidel Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-10-31
- Decision date
- 2012-12-13
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- OZN
- Device class
- 2
- Regulation number
- 866.3130
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.