WALLAC OY

FDA Device Registration & Listing · TURKU Varsinais-Suomi, FI · Registration 8043909

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8043909
FEI Number
3002808498
Entity Name
WALLAC OY
City/State/Country
TURKU Varsinais-Suomi, FI
Establishment Address
MUSTIONKATU 6, TURKU Varsinais-Suomi 20750, FI
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Revvity, Inc. (Owner Number: 9912035)
Owner / Operator Contact Address
77 4th Avenue, Waltham, MA 02451, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K173829
PMA Number
N/A

All Registered Proprietary Names

AutoDELFIA Neonatal 17 a-OH-progesterone (B024-104, B024-112) GSP Neonatal GALT Kit (3303-001U) DELFIA Trio (1296-0070) Panthera-Puncher 9 (2081-0010) Infusence™ Infusion Pump (2040-0050) DELFIA Dried Blood Spot Puncher (1296-071) DELFIA Wash Concentrate (PN B117-100, 1244-114, 4010-0010) DELFIA Enhancement Solution (B118-100, 1244-104, 1244-105) DELFIA Diluent 2 (B131-100, B132-100, B138-100) DELFIA Inducer (3304-0010) GSP Wash Concentrate (4080-0010) DELFIA Diluent 3 (4021-0010, 4022-0010) Buffer M (4402-0010) Eonis SCID-SMA Kit (3242-001U) Eonis SCID-SMA Kit (3241-001U) EnLite Neonatal TREC kit (3401-001U, 3402-001U, 3403-001U) RESOLVE Hb FASC Control Kit (3412-0010) AutoDELFIA Neonatal IRT kit (B005-204, B005-212) GSP Neonatal Thyroxine (T4) kit (3302-001U) AutoDELFIA Neonatal Thyroxine (T4) (B065-112) DELFIA Neonatal Thyroxine (T4) kit (A065-110) GSP Neonatal Creatine Kinase-MM kit (3311-001U) Iduronate 2-sulfatase SIS (4400-0010) LysoPC IS (4417-0010) NeoBase Non-derivatized Assay Solutions (3041-0020) NeoBase Non-derivatized MSMS kit (3040-001U) NeoBase Succinylacetone Assay Solution (3042-0020) Hb Elution Solution (3024-0010, 3025-0010) JB-2 Staining System (FR-9367) RESOLVE Hemoglobin kit (FR-9120, FR-9360, FR-9400) AutoDELFIA hCG kit (B007-112) Neonatal Biotinidase Kit (3018-0010, 3018-001B) GSP Neonatal Biotinidase (3307-001U) GSP® Neonatal Total Galactose kit (3309-002U) MSMS Workstation Software (5002-0540) Eonis Analysis Software (5020-1000) AutoDELFIA Inhibin A kit (B064-112) AutoDELFIA Inhibin A kit Level Calibrators (B064-112-P2) GSP Instrument including software (2021-0010) GSP Neonatal hTSH kit (3301-001U) Chemagic Prepito D (2022-0020) chemagic DNA CS200 kit (3207-0010) chemagic 360-D (2024-0010) Eonis DNA Extraction kit (3240-001U) NeoBase Non-Derivatized MSMS Kit (3040-001U) NeoBase Succinylacetone Assay Solution (3042-0020) NeoBase Non-Derivatized Assay Solutions (3041-0020) Neonatal GALT (NG-1100, NG-4100) Neonatal Total Galactose (3029-0010) DELFIA hLH Spec (A031-101) NeoLSD MSMS kit (3093-004U) NeoLSD MSMS kit (3093-001U)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OHQ Multi-Analyte Controls Unassayed Clinical Chemistry Class 1 862.1660 2022-08-19
JLX Radioimmunoassay, 17-Hydroxyprogesterone Clinical Chemistry Class 1 862.1395 2009-04-17
KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase Clinical Chemistry Class 2 862.1315 2010-07-16
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2005-02-28
PPM General Purpose Reagent Pathology Class 1 864.4010 2016-08-21
QUE Spinal Muscular Atrophy Newborn Screening Test System Immunology Class 2 866.5980 2022-11-23
PJI Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System Immunology Class 2 866.5930 2014-12-16
JCM Control, Hemoglobin, Abnormal Hematology Class 2 864.7415 2021-11-19
JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin Clinical Chemistry Class 1 862.1725 2011-06-27
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2011-04-26
CDX Radioimmunoassay, Total Thyroxine Clinical Chemistry Class 2 862.1700 2008-01-03
QJE Muscular Dystrophy Newborn Screening Test Clinical Chemistry Class 2 862.1506 2019-12-20
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2022-07-11
NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Clinical Chemistry Class 2 862.1055 2018-11-20
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2008-04-16
JHJ Agglutination Method, Human Chorionic Gonadotropin Clinical Chemistry Class 2 862.1155 2008-02-29
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2010-03-11
NAK System, Test, Biotinidase Clinical Chemistry Class 2 862.1118 2010-03-11
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2010-03-11
NAK System, Test, Biotinidase Clinical Chemistry Class 2 862.1118 2013-11-28
JIA Enzymatic Methods, Galactose Clinical Chemistry Class 1 862.1310 2019-11-27
JQP Calculator/Data Processing Module, For Clinical Use Clinical Chemistry Class 1 862.2100 2005-04-08
NDR Enzyme Immunoassay, Inhibin-A Clinical Chemistry Class 1 862.1260 2015-03-09
JLW Radioimmunoassay, Thyroid-Stimulating Hormone Clinical Chemistry Class 2 862.1690 2009-09-08
KHO Fluorometer, For Clinical Use Clinical Chemistry Class 1 862.2560 2009-09-08
JJH Clinical Sample Concentrator Clinical Chemistry Class 1 862.2310 2012-05-21
NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Clinical Chemistry Class 2 862.1055 2009-07-13
KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase Clinical Chemistry Class 2 862.1315 2007-12-19
JJT Enzyme Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2007-12-19
JIA Enzymatic Methods, Galactose Clinical Chemistry Class 1 862.1310 2008-09-15
CEP Radioimmunoassay, Luteinizing Hormone Clinical Chemistry Class 1 862.1485 1992-05-21
QCM ß-Galactocerebrosidase (Galc) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24
PQU Alpha-D-Glucosidase (Gaa) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24
QCL Acid-Sphingomyelinase (Asm) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24
PQV ß-Glucocerebrosidase (Gba) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24
PQT Alpha-L-Iduronidase (Idua) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24
PQW Alpha-D-Galactosidase A (Gla) Newborn Screening Test System Clinical Chemistry Class 2 862.1488 2018-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Castellanos Business: Revvity, Inc. Email: americas.regulatory@revvity.com Phone: (973) 5808347

Related Public Records

Same Entity

Revvity, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3032324401 Revvity Discovery Limited Cambrige Cambridgeshire, GB
3004049804 Revvity Singapore Pte Ltd Singapore Central Singapore, SG
3007145015 Revvity Health Sciences, Inc. Greenville, SC, US
3009981484 Revvity Health Sciences, Inc. Hopkinton, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K941042 Microgenics Corp. CEDIA T4 MAB ASSAY 1994-04-26
K082638 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL 2009-02-26
K834595 Beckman Instruments, Inc. PARAGON ACID HEMOGLOBIN REAGENT KIT 1984-05-07
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043909. Last updated year: 2026. Please use registration number 8043909 when referencing this establishment in official correspondence.
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