QUANTA LITE M2 EP (MIT3) ELISA— 510(k) K052262
Substantially EquivalentInova Diagnostics, Inc.
FDA 510(k) clearance K052262 for QUANTA LITE M2 EP (MIT3) ELISA, Substantially Equivalent on 2005-10-27. Applicant: Inova Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Inova Diagnostics, Inc.
- Product code
- Code DBM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5090
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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