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Rapid Response 04GLU-49

by BTNX Inc

Rapid Response 04GLU-49 is a Class II device made by BTNX Inc, cleared under FDA 510(k) K063212 on 22 Nov 2006 and listed in FDA GUDID since 5 Feb 2019 (UDI-DI 00722066003183), 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) K063212

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 Number00722066003183 UDI-DI Date5 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK063212 Date22 Nov 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063212 decided 22 Nov 2006 Active
  • FDA GUDID UDI-DI 00722066003183 listed 5 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063212
  2. Listed FDA GUDID 00722066003183

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  • Withdrawn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
Glucose monitoring system IVD, home-use
Model / reference
04GLU-49
Primary DI / UDI-DI
00722066003183
510(k) Number
FDA product code
NBW, CGA
GMDN term
Glucose monitoring system IVD, home-use
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose monitoring system IVD, home-use

Cleared under the same submission (K063212)

and 3 more cleared under K063212

Similar devices

Other devices filed under FDA product code NBW (System, Test, Blood Glucose, Over The Counter).

Other devices from BTNX Inc

See all devices from BTNX Inc →

Properties

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