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Rapid Response D4.57-1V

by BTNX Inc

Rapid Response D4.57-1V is a Class II device made by BTNX Inc, cleared under FDA 510(k) K180349 on 5 Apr 2018 and listed in FDA GUDID since 1 Apr 2024 (UDI-DI 10722066007409), active as of 23 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 23 Oct 2026

Documents

510(k) K180349

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10722066007409 UDI-DI Date1 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180349 Date5 Apr 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180349 decided 5 Apr 2018 Active
  • FDA GUDID UDI-DI 10722066007409 listed 1 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180349
  2. Listed FDA GUDID 10722066007409

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rapid Response
Generic name
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Model / reference
D4.57-1V
Primary DI / UDI-DI
10722066007409
510(k) Number
FDA product code
NGL, NFT, NFY, NGG
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3650, 862.3100, 862.3250, 862.3610
GUDID distribution status
In Commercial Distribution

Related devices

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

Cleared under the same submission (K180349)

and 8 more cleared under K180349

Similar devices

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

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Over-the-counter
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)