Skip to content

Architect 6K49-02

by Abbott Laboratories

Architect 6K49-02 (06K4902) is a Class I device made by Abbott Laboratories, cleared under FDA 510(k) K040879 on 10 May 2004 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740030094), 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) K040879

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 Number00380740030094 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040879 Date10 May 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040879 decided 10 May 2004 Active
  • FDA GUDID UDI-DI 00380740030094 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040879
  2. Listed FDA GUDID 00380740030094

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  • Withdrawn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
Ferritin IVD, calibrator
Model / Ref / Catalog
6K49-02, 06K4902
Primary DI / UDI-DI
00380740030094
510(k) Number
FDA product code
JJX, DBF, JIT
GMDN term
Ferritin IVD, calibrator
Device class
Class I
Regulation number
862.1660, 866.5340, 862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ferritin IVD, calibrator

Cleared under the same submission (K040879)

Similar devices

Other devices filed under FDA product code JJX (SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)).

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)