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Alinity 09P8720

by Abbott Laboratories

Alinity 09P8720 is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K943414 on 9 Sep 1994 and listed in FDA GUDID since 10 Oct 2019 (UDI-DI 00380740165307), 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) K943414

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 Number00380740165307 UDI-DI Date10 Oct 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK943414 Date9 Sep 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K943414 decided 9 Sep 1994 Active
  • FDA GUDID UDI-DI 00380740165307 listed 10 Oct 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K943414
  2. Listed FDA GUDID 00380740165307

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  • Withdrawn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
Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
09P8720
Primary DI / UDI-DI
00380740165307
510(k) Number
FDA product code
JXN
GMDN term
Propoxyphene IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
862.3700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Propoxyphene IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K943414)

Similar devices

Other devices filed under FDA product code JXN (Enzyme immunoassay, propoxyphene).

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)