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Gsp Neonatal Irt Kit (3306-001U)

by Wallac Oy, Subsidiary of Perkinelmer

510(k) K102419Ref 3306-0010

Active European Union and United States

CE IVDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102419↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-06438147320516 Basic UDI-DI 06438147320516UDI-DIDate22 Aug 2022RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK102419 Date16 Dec 2010ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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 · 510(k)

Trade Name
GSP Neonatal IRT kit
Model / Reference
3306-0010
Primary DI / UDI-DI
06438147320516
Basic UDI-DI
B-06438147320516
510(k) Number
FDA Product Code
JNO
EMDN Code
W0102019007 Immuno reactive trypsin
Device Class
Class IVD General EUDAMED
Class I 510(k)
Regulation
21 CFR Part 862.1725
EU market of registration
Finland
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IVD General
510(k)
Class I

Other devices from Wallac Oy, A Subsidiary of Perkinelmer, Inc.

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No