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T-Tek

by R 2 Diagnostics, Inc.

510(k) K050817Ref 50-201

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050817↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-10859394006054 Basic UDI-DI 10859394006054UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10859394006054 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK050817 Date12 Dec 2005ClearedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10859394006054 registered 20 May 2026 Active
  • FDA 510(k) K050817 decided 12 Dec 2005 Active
  • FDA GUDID UDI-DI 10859394006054 listed 15 Nov 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K050817
  2. Listed FDA GUDID 10859394006054
  3. Registered EUDAMED B-10859394006054

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Generic name
Thrombin time (TT) IVD, kit, clotting
Model / Ref / Catalog
50-201
FDA applicant
R2 Diagnostics, Inc.
Primary DI / UDI-DI
10859394006054
Basic UDI-DI
B-10859394006054
510(k) Number
FDA product code
GJA
EMDN code
W0103020103 Thrombin time / reptilase / batroxobin time
GMDN term
Thrombin time (TT) IVD, kit, clotting
Device class
Class IVD General EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 864.7875
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device classEUDAMED
Class IVD General
510(k)
Class II
GUDID
Class II

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA 510(k), FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The T-Tek Thrombin Time Reagent is a diagnostic in vitro device classified under the nomenclature for coagulation tests. It is designed for the quantitative measurement of thrombin time (TT) in citrated human plasma, a key parameter in assessing blood coagulation function and identifying potential clotting disorders.

This reagent is intended for use exclusively in clinical laboratories by qualified personnel, compatible with manual or semi-automated/automated coagulation analyzers. Supplied as a sterile, single-use reagent, it adheres to FDA 510(k) clearance (K050817) and IVDD compliance, with regulatory classification as a Class II device (GJA product code). Storage and handling follow standard laboratory protocols for coagulation reagents.

Devices cleared under K050817

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K050817
UDI-DISize and differences
T-tek 50-201
r2 Diagnostics Inc.
50-201 / 50-20110859394006054 —On the market

Similar devices in this category

Other devices filed under THROMBIN TIME / REPTILASE / BATROXOBIN TIME.

Other devices from R 2 Diagnostics, Inc.

See all devices from R 2 Diagnostics, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)