510(k) K220085
- Device
- KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
- Applicant
- Kronus, Inc.
- 510(k) number
- K220085
- Product code
- OIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-24
- Date received
- 2022-01-11
- Regulation
- 866.5660
- Classification name
- Tyrosine Phosphatase (Ia-2) Autoantibody Assay
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Delaney Sauer
- Address
- 170 S. Seneca Springs Way Suite 105 Star ID US 83669 83669
FDA Registration Numbers#
- 3003834021
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA