KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
FDA 510(k) clearance K220085 · decided 2023-08-24
Clearance details
- K-number
- K220085
- Device name
- KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
- Applicant
- Kronus, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-11
- Decision date
- 2023-08-24
- Days to decision
- 590 days
- Clearance type
- Traditional
- Product code
- OIF
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Star, ID, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K171731) | Kronus, Inc. | 2018-01-19 |
| KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (K073590) | Kronus Market Development Associates, Inc. | 2008-04-10 |
Recalls involving this device
No recalls on record reference this clearance.