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QBC Diagnostics 424305

by Drucker Diagnostics

QBC Diagnostics 424305 is a Class II device made by Drucker Diagnostics, cleared under FDA 510(k) K984099 on 10 Dec 1998 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 00858092006543), active as of 22 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 22 Oct 2026

Documents

510(k) K984099

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858092006543 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK984099 Date10 Dec 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K984099 decided 10 Dec 1998 Active
  • FDA GUDID UDI-DI 00858092006543 listed 2 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K984099
  2. Listed FDA GUDID 00858092006543

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
QBC Diagnostics
Generic name
Full blood count IVD, control
Model / Ref / Catalog
424305
Primary DI / UDI-DI
00858092006543
510(k) Number
FDA product code
JPK
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 (K984099)

Similar devices in this category

Other devices filed under Full blood count IVD, control.

Other devices from Drucker Diagnostics

See all devices from Drucker Diagnostics →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)