HbA1C HA3830
HbA1C HA3830 is a Class II device made by Randox Laboratories, Ltd., cleared under FDA 510(k) K021897 on 26 Nov 2002 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 05055273203561), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05055273203561 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK021897 | Date26 Nov 2002 | StatusActive |
Official records
- AccessGUDID record 05055273203561
- FDA 510(k) database K021897
Across registries
- FDA 510(k) K021897 decided 26 Nov 2002 Active
- FDA GUDID UDI-DI 05055273203561 listed 16 Sep 2016 Listed
Recalls
-
- Terminated Z-0285-2018
Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of the product.
Timeline
- Cleared FDA 510(k) K021897
- Listed FDA GUDID 05055273203561
- Recall initiated FDA recalls Z-0285-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- HbA1C
- Generic name
- Glycated haemoglobin (HbA1c) IVD, reagent
- Model / Ref / Catalog
- HA3830
- Primary DI / UDI-DI
- 05055273203561
- 510(k) Number
- FDA product code
- LCP
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, reagent
- Device class
- Class II
- Regulation number
- 864.7470
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Glycated haemoglobin (HbA1c) IVD, reagent.