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iScreen™ ABTDOXW11401A

by Instant Technologies, Inc.

iScreen ABTDOXW11401A is a multiple drugs of abuse IVD (FDA Class II; FDA product code NGL, Test, Opiates, Over The Counter) made by Instant Technologies, Inc., cleared under FDA 510(k) K202567 on 25 Sep 2020 and listed in FDA GUDID since 10 Feb 2023 (UDI-DI 00817405023783), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K202567

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817405023783 UDI-DI Date10 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202567 Date25 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202567 decided 25 Sep 2020 Active
  • FDA GUDID UDI-DI 00817405023783 listed 10 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202567
  2. Listed FDA GUDID 00817405023783

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
iScreen™
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
ABTDOXW11401A
Description
OXY PANEL CLIA WAIVED DIP CARD OXY100
Primary DI / UDI-DI
00817405023783
510(k) Number
FDA product code
NGL
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3650
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K202567)

and 8 more cleared under K202567

Similar devices

Other devices filed under FDA product code NGL (Test, Opiates, Over The Counter).

Other devices from Instant Technologies, Inc.

See all devices from Instant Technologies, Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)