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Rapid Response D10.32-1V

by BTNX Inc

Rapid Response D10.32-1V 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 9 Jan 2020 (UDI-DI 00722066005088), 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) K180349

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 Number00722066005088 UDI-DI Date9 Jan 2020ListedStatusListed 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 00722066005088 listed 9 Jan 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180349
  2. Listed FDA GUDID 00722066005088

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  • Withdrawn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
D10.32-1V
Primary DI / UDI-DI
00722066005088
510(k) Number
FDA product code
NFY, NGL, PTG, NGM, PTH, NFT, NFV, NGG
GMDN term
Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
862.3250, 862.3650, 862.3620, 862.3150, 862.3100, 862.3170, 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 in this category

Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)