Architect 6K41-50

by Abbott Laboratories

Architect 6K41-50 (06K4150) is a Class II 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 00380740057718), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00380740057718 UDI-DI	Date9 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK040879	Date10 May 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00380740057718
FDA 510(k) database 510(k) number K040879

Across registries

2 registries list this device

FDA 510(k) K040879 decided 10 May 2004 Active
FDA GUDID UDI-DI 00380740057718 listed 9 Sep 2016 Listed

Timeline

2 dated events

10 May 2004 Cleared FDA 510(k) K040879
9 Sep 2016 Listed FDA GUDID 00380740057718

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Architect
Generic name: Ferritin IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog: 6K41-50, 06K4150

Primary DI / UDI-DI: 00380740057718
510(k) Number: K040879
FDA product code: DBF, JJX, JIT
GMDN term: Ferritin IVD, kit, nephelometry/turbidimetry

Device class: Class II
Regulation number: 866.5340, 862.1660, 862.1150
GUDID distribution status: In Commercial Distribution

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Properties

Contains latex
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (10, all answered No)