QUANTA PLEX ANCA PROFILE— 510(k) K050715
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K050715 for QUANTA PLEX ANCA PROFILE, Substantially Equivalent on 2005-05-12. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code MOB
- 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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More clearances from Inova Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.