Kenota 1 Total IgE; Kenota 1 (instrument)
FDA 510(k) K231151 · Kenota, Inc.
510(k) numberK231151
Submission
- Device name
- Kenota 1 Total IgE; Kenota 1 (instrument)
- Applicant
- Kenota, Inc.
Kitchener, CA - Received
- April 24, 2023
- Decision date
- May 31, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
Other 510(k)s with product code DGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K214068 | Quantia IgEDGC · Special | Biokit, S.A. | 02/21/2023SE |
| K220178 | Total Immunoglobulin E (IgE)DGC · Traditional | Beckman Coulter, Inc. | 03/23/2022SE |
| K193493 | ADVIA Centaur Total IgE (tIgE)DGC · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/15/2020SE |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…DGC · Special | Phadia AB | 07/28/2016SE |
| K133404 | Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMHDGC · Special | Phadia AB | 02/24/2014SE |
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…DGC · Traditional | Dade Behring, Inc. | 02/15/2007SE |
| K050493 | Quantia IgeDGC · Traditional | Biokit, S.A. | 08/16/2005SE |
| K042241 | K-Assay Total Ige, K-Assay Ige Calibrator Set, Models KAI-092/KAI-093CDGC · Traditional | Kamiya Biomedical Co. | 12/10/2004SE |
| K034057 | LacrytestDGC · Traditional | Adiatec SA | 03/09/2004SE |
| K032251 | Immunetech Total Ige SystemDGC · Traditional | Immunetech Corporation | 12/19/2003SE |
Questions and answers
When was Kenota 1 Total IgE; Kenota 1 (instrument) cleared by the FDA?
Kenota 1 Total IgE; Kenota 1 (instrument) (K231151) received a 510(k) decision of Substantially Equivalent on May 31, 2024, 403 days after the submission was received.
What is the product code of K231151?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.