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Architect 2K43-10

by Abbott Ireland Diagnostics

Ref 02K4310

Architect 2K43-10 (02K4310) is a device classified as Class C in the EU and Class I in the US made by Abbott Ireland Diagnostics, registered in EUDAMED on 15 Aug 2026 (Basic UDI-DI 038074ARK0243MF), cleared under FDA 510(k) K013995 on 21 Dec 2001 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003289), active as of 24 Oct 2026.

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

CE IVDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K013995

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074ARK0243MF Basic UDI-DI 00380740003289UDI-DIDate15 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740003289 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK013995 Date21 Dec 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 038074ARK0243MF registered 15 Aug 2026 Active
  • FDA 510(k) K013995 decided 21 Dec 2001 Active
  • FDA GUDID UDI-DI 00380740003289 listed 6 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K013995
  2. Listed FDA GUDID 00380740003289
  3. Registered EUDAMED 038074ARK0243MF

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Architect
Generic name
Myoglobin IVD, control
Device name
ARCHITECT STAT Myoglobin
Model / Ref / Catalog
02K4310, 2K43-10
Primary DI / UDI-DI
00380740003289
Basic UDI-DI
038074ARK0243MF
510(k) Number
FDA product code
JJY
EMDN code
W0102152004 Cardiac marker controls
GMDN term
Myoglobin IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
02K4310
GUDID
2K43-10
Device classEUDAMED
Class C
GUDID
Class I

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

Related devices

Category: Myoglobin IVD, control

Cleared under the same submission (K013995)

Similar devices in this category

Other devices filed under CARDIAC MARKER CONTROLS.

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

  • Contains latex
  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (15, all answered No)