QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents— 510(k) K190088
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K190088 for QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents, Substantially Equivalent on 2019-04-17. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- 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.
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