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CT1647B

by Oxoid Limited

CT1647B is a Class II device made by Oxoid Limited, cleared under FDA 510(k) K982517 on 9 Sep 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05032384095810), 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) K982517

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 Number05032384095810 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982517 Date9 Sep 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982517 decided 9 Sep 1998 Active
  • FDA GUDID UDI-DI 05032384095810 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982517
  2. Listed FDA GUDID 05032384095810

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Cefprozil susceptibility testing disc IVD
Model / reference
CT1647B
Primary DI / UDI-DI
05032384095810
510(k) Number
FDA product code
JTN
GMDN term
Cefprozil susceptibility testing disc IVD
Device class
Class II
Regulation number
866.1620
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cefprozil susceptibility testing disc IVD

Similar devices

Other devices filed under FDA product code JTN (Susceptibility Test Discs, Antimicrobial).

Other devices from Oxoid Limited

See all devices from Oxoid Limited →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)