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Sickledex 217660

by Streck

Sickledex 217660 is a Class II device made by Streck, cleared under FDA 510(k) K023656 on 30 Dec 2002, registered in EUDAMED and listed in FDA GUDID since 19 Sep 2016 (UDI-DI 00844509002031), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K023656

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00844509002031 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK023656 Date30 Dec 2002DecidedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K023656 decided 30 Dec 2002 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 00844509002031 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K023656
  2. Listed FDA GUDID 00844509002031

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sickledex
Generic name
Haemoglobin S (HbS) IVD, control
Model / Ref / Catalog
217660
Description
A qualitative solubility test kit used to detect the presence of sickling hemoglobins in human blood or sickle cell control material. Contains 50 tests.
Primary DI / UDI-DI
00844509002031
510(k) Number
FDA product code
GHM
GMDN term
Haemoglobin S (HbS) IVD, control
Device class
Class II
Regulation number
864.7825
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemoglobin S (HbS) IVD, control

Cleared under the same submission (K023656)

Similar devices

Other devices filed under FDA product code GHM (Test, Sickle Cell).

Other devices from Streck

See all devices from Streck →

Properties

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