Device product
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
Z-1603-2023
Product summary
- Event
- Event 92131
- Status
- Completed
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-1603-2023
Official wording
Reason: Marketed without a 510k
Code information: UDI: (01) 04050598000582 PN K6870/Lot Numbers: 220706 Exp. 05/04/2024; 221122 Exp. 06/07/2024. P/N:K6870.20.US.L Lot Numbers: 221124 Exp:07/29/2025, 230102 Exp: 10/24/2025
Distribution pattern: US Nationwide Distribution: CA, IL, NC, NH, OR
Derived failure modes
-
Unknown
Marketed without a 510k