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Uibc-Sl 153-10

by Sekisui Diagnostics, LLC

Ref 153-10

Uibc-Sl 153-10 is a device classified as IVD General (EU), Class I (US) made by Sekisui Diagnostics, LLC, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-00628063400928), cleared under FDA 510(k) K963116 on 20 Aug 1996 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00628063400928), active as of 7 Nov 2026.

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

CE IVDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K963116

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00628063400928 Basic UDI-DI 00628063400928UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00628063400928 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK963116 Date20 Aug 1996DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00628063400928 registered 16 Oct 2026 Active
  • FDA 510(k) K963116 decided 20 Aug 1996 Active
  • FDA GUDID UDI-DI 00628063400928 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K963116
  2. Listed FDA GUDID 00628063400928
  3. Registered EUDAMED B-00628063400928

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Unbound Iron Binding Capacity (Uibc)-Sl Assay EUDAMED
Uibc-Sl GUDID
Generic name
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
Model / Ref / Catalog
153-10
Primary DI / UDI-DI
00628063400928
Basic UDI-DI
B-00628063400928
510(k) Number
FDA product code
JMO
EMDN code
W01010217, W01019001
GMDN term
Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1415
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IVD General
GUDID
Class I

Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Unsaturated iron binding capacity (UIBC) IVD, kit, spectrophotometry

Cleared under the same submission (K963116)

Similar devices in this category

Other devices filed under IRON BINDING CAPACITY - TOTAL (CC).

Other devices from Sekisui Diagnostics, LLC

See all devices from Sekisui Diagnostics, LLC →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)