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Icon 395100

by Beckman Coulter, Inc.

Icon 395100 is a Class II device made by Beckman Coulter, Inc., cleared under FDA 510(k) K961024 on 4 Feb 1997 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 15099590625900), 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) K961024

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 Number15099590625900 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK961024 Date4 Feb 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K961024 decided 4 Feb 1997 Active
  • FDA GUDID UDI-DI 15099590625900 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K961024
  2. Listed FDA GUDID 15099590625900

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Icon
Generic name
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
395100
Primary DI / UDI-DI
15099590625900
510(k) Number
FDA product code
KTN
GMDN term
Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
866.5640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical

Cleared under the same submission (K961024)

Similar devices in this category

Other devices filed under Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Prescription use
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)