QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY— 510(k) K123998
Substantially EquivalentQuidel Corp.
FDA 510(k) clearance K123998 for QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY, Substantially Equivalent on 2013-03-08. Applicant: Quidel Corp.. Device class: 2.
Clearance details
- Applicant
- Quidel Corp.
- 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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