MarDx 40-8696G
MarDx 40-8696G is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K894224 on 21 Aug 1989 and listed in FDA GUDID since 25 Oct 2019 (UDI-DI 05391516746625), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391516746625 | Date25 Oct 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK894224 | Date21 Aug 1989 | StatusActive |
Official records
- AccessGUDID record 05391516746625
- FDA 510(k) database K894224
Across registries
- FDA 510(k) K894224 decided 21 Aug 1989 Active
- FDA GUDID UDI-DI 05391516746625 listed 25 Oct 2019 Listed
Timeline
- Cleared FDA 510(k) K894224
- Listed FDA GUDID 05391516746625
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MarDx
- Generic name
- Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Model / Ref / Catalog
- 40-8696G
- Primary DI / UDI-DI
- 05391516746625
- 510(k) Number
- FDA product code
- LSR
- GMDN term
- Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
- Device class
- Class II
- Regulation number
- 866.3830
- GUDID distribution status
- In Commercial Distribution