QUANTA LITE RF IGA ELISA— 510(k) K983084
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K983084 for QUANTA LITE RF IGA ELISA, Substantially Equivalent on 1998-11-04. 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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