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Statdip® Sdp-364-0

by Micro Distributing, L.c

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K133968; other models may be affected

Documents

510(k) K133968

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816036025760 UDI-DI Date4 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK133968 Date25 Feb 2014DecidedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1589-2022 FDA Class II initiated 25 May 2022 on shared 510(k) K133968

    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.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Statdip®
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
SDP-364-0
Primary DI / UDI-DI
00816036025760
510(k) Number
FDA product code
LAF, DIO, LDJ, DJG, JXM
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3610, 862.3250, 862.3870, 862.3650, 862.3170
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple drugs of abuse IVD, kit, rapid ICT, clinical

Cleared under the same submission (K133968)

Show all (12)

Other devices from Micro Distributing, L.c

See all devices from Micro Distributing, L.c →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No