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Thermo Scientific Infinity™ TR15421

by Fisher Diagnostics

Thermo Scientific Infinity™ TR15421 is a Class II device made by Fisher Diagnostics, cleared under FDA 510(k) K980026 on 10 Mar 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00845275002423), 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) K980026

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 Number00845275002423 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980026 Date10 Mar 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980026 decided 10 Mar 1998 Active
  • FDA GUDID UDI-DI 00845275002423 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980026
  2. Listed FDA GUDID 00845275002423

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Thermo Scientific Infinity™
Generic name
Glucose IVD, reagent
Model / reference
TR15421
Primary DI / UDI-DI
00845275002423
510(k) Number
FDA product code
CFR
GMDN term
Glucose IVD, reagent
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose IVD, reagent

Similar devices

Other devices filed under FDA product code CFR (Hexokinase, Glucose).

Other devices from Fisher Diagnostics

See all devices from Fisher Diagnostics →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)