Kenota 1 Total IgE; Kenota 1 (instrument)— 510(k) K231151
Substantially EquivalentKenota, Inc.
FDA 510(k) clearance K231151 for Kenota 1 Total IgE; Kenota 1 (instrument), Substantially Equivalent on 2024-05-31. Applicant: Kenota, Inc.. Device class: 2.
Clearance details
- Applicant
- Kenota, 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
- Dual Track
- Location
- Kitchener, CA
Recent devices under product code DGC
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- K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH
Data sourced from openFDA. This site is unofficial and independent of the FDA.