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Architect 2K41-10

by Abbott Laboratories

Architect 2K41-10 (02K4110) is a Class I device made by Abbott Laboratories, cleared under FDA 510(k) K041194 on 16 Aug 2004 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740003197), 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) K041194

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 Number00380740003197 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041194 Date16 Aug 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041194 decided 16 Aug 2004 Active
  • FDA GUDID UDI-DI 00380740003197 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K041194
  2. Listed FDA GUDID 00380740003197

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Architect
Generic name
Troponin I IVD, control
Model / Ref / Catalog
2K41-10, 02K4110
Primary DI / UDI-DI
00380740003197
510(k) Number
FDA product code
JJX
GMDN term
Troponin I IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Troponin I IVD, control

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Other devices filed under Troponin I IVD, control.

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Properties

  • Contains latex
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)