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Alinity 08P5520

by Abbott Laboratories

Alinity 08P5520 is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K060709 on 15 Jun 2006 and listed in FDA GUDID since 31 Dec 2018 (UDI-DI 00380740135522), 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) K060709

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 Number00380740135522 UDI-DI Date31 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK060709 Date15 Jun 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060709 decided 15 Jun 2006 Active
  • FDA GUDID UDI-DI 00380740135522 listed 31 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060709
  2. Listed FDA GUDID 00380740135522

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alinity
Generic name
Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
08P5520
Primary DI / UDI-DI
00380740135522
510(k) Number
FDA product code
LCD
GMDN term
Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Device class
Class II
Regulation number
862.3450
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay

Cleared under the same submission (K060709)

Similar devices

Other devices filed under FDA product code LCD (ENZYME IMMUNOASSAY, GENTAMICIN).

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)