QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA— 510(k) K120817
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K120817 for QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA, Substantially Equivalent on 2013-02-26. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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