Statdip® Sdp-2124-0
Statdip® Sdp-2124-0 is a Class II device made by Micro Distributing, L.c, cleared under FDA 510(k) K133968 on 25 Feb 2014 and listed in FDA GUDID since 4 Dec 2017 (UDI-DI 00816036025944), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816036025944 | Date4 Dec 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133968 | Date25 Feb 2014 | StatusActive |
Official records
- AccessGUDID record 00816036025944
- FDA 510(k) database K133968
Across registries
- FDA 510(k) K133968 decided 25 Feb 2014 Active
- FDA GUDID UDI-DI 00816036025944 listed 4 Dec 2017 Listed
Recalls
-
- Ongoing Z-1589-2022
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Timeline
- Cleared FDA 510(k) K133968
- Listed FDA GUDID 00816036025944
- Recall initiated FDA recalls Z-1589-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Statdip®
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- SDP-2124-0
- Primary DI / UDI-DI
- 00816036025944
- 510(k) Number
- FDA product code
- LFG, DJR, DIS, LAF, DIO, LDJ, DJG, JXM, DKZ, LCM
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3910, 862.3620, 862.3150, 862.3610, 862.3250, 862.3870, 862.3650, 862.3170, 862.3100
- GUDID distribution status
- In Commercial Distribution