Architect 07K0041

by Abbott Laboratories

Architect 07K0041 is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K050487 on 26 Apr 2005 and listed in FDA GUDID since 3 Mar 2020 (UDI-DI 00380740156435), 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	Number00380740156435 UDI-DI	Date3 Mar 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK050487	Date26 Apr 2005Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00380740156435
FDA 510(k) database 510(k) number K050487

Across registries

2 registries list this device

FDA 510(k) K050487 decided 26 Apr 2005 Active
FDA GUDID UDI-DI 00380740156435 listed 3 Mar 2020 Listed

Timeline

2 dated events

26 Apr 2005 Cleared FDA 510(k) K050487
3 Mar 2020 Listed FDA GUDID 00380740156435

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Architect
Generic name: Lipoprotein A IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog: 07K0041

Primary DI / UDI-DI: 00380740156435
510(k) Number: K050487
FDA product code: DFC, JJX, JIS
GMDN term: Lipoprotein A IVD, kit, nephelometry/turbidimetry

Device class: Class II
Regulation number: 866.5600, 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)