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Cell-Dyn 09H69-02

by Abbott Laboratories

Cell-Dyn 09H69-02 (09H6902) is a Class II device made by Abbott Laboratories, cleared under FDA 510(k) K823498 on 28 Dec 1982 and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740020330), 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) K823498

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 Number00380740020330 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK823498 Date28 Dec 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K823498 decided 28 Dec 1982 Active
  • FDA GUDID UDI-DI 00380740020330 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K823498
  2. Listed FDA GUDID 00380740020330

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cell-Dyn
Generic name
Full blood count IVD, control
Model / Ref / Catalog
09H69-02, 09H6902
Primary DI / UDI-DI
00380740020330
510(k) Number
FDA product code
GLQ
GMDN term
Full blood count IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Full blood count IVD, control

Cleared under the same submission (K823498)

and 2 more cleared under K823498

Similar devices in this category

Other devices filed under Full blood count IVD, control.

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)