TOTAL IGE-FAST TEST— 510(k) K823494
Substantially EquivalentAxonics, Inc.
FDA 510(k) clearance K823494 for TOTAL IGE-FAST TEST, Substantially Equivalent on 1983-01-14. Applicant: Axonics, Inc.. Device class: 2.
Clearance details
- Applicant
- Axonics, Inc.
- Product code
- Code DGC
- Device class
- Class 2
- Regulation
- 21 CFR 866.5510
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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