Data / Medical devices / Finland / Wallac OY
Wallac OY: FDA-registered device maker in TURKU Varsinais-Suomi, Finland, 26 510(k) clearances and 1 PMA approval
Wallac OY is registered with the FDA (registration 8043909) in TURKU Varsinais-Suomi, Finland. It lists 40 device types. The FDA files 26 510(k) clearances and 1 PMA approval under its listings, the newest dated November 9, 2022. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8043909
- FEI number
- 3002808498
- Address
- Mustionkatu 6, TURKU Varsinais-Suomi, Finland, 20750
- Owner or operator
- Revvity, Inc. (9912035)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- May 21, 1992
- Registered through
- 2026
- Brand names listed
- AutoDELFIA Inhibin A kit (B064-112), AutoDELFIA Inhibin A kit Level Calibrators (B064-112-P2), AutoDELFIA Neonatal 17 a-OH-progesterone (B024-104, B024-112), AutoDELFIA Neonatal IRT kit (B005-204, B005-212), AutoDELFIA Neonatal Thyroxine (T4) (B065-112), AutoDELFIA Neonatal hTSH kit (B032-312), AutoDELFIA Unconjugated Estriol (uE3) (B095-101U, B095-112), AutoDELFIA hAFP kit (B079-212) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abnormal Hemoglobin Quantitation | GKA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Acid-Sphingomyelinase (Asm) Newborn Screening Test System | QCL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Agglutination Method, Human Chorionic Gonadotropin | JHJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | PQW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | PQU | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Alpha-L-Iduronidase (Idua) Newborn Screening Test System | PQT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Apparatus, Electrophoresis, For Clinical Use | JJN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Block, Heating | JRG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clinical Sample Concentrator | JJH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Control, Hemoglobin, Abnormal | JCM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzymatic Methods, Galactose | JIA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzyme Controls (Assayed And Unassayed) | JJT | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Inhibin-A | NDR | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | KQP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fluorometer, For Clinical Use | KHO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Kit, Test, Alpha-Fetoprotein For Neural Tube Defects | LOK | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mass Spectrometer, Clinical Use | DOP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Multi-Analyte Controls Unassayed | OHQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Muscular Dystrophy Newborn Screening Test | QJE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin | JNO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | JNB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Estriol | CGI | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Luteinizing Hormone | CEP | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Radioimmunoassay, Total Thyroxine | CDX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Reagents, Specific, Analyte | MVU | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System | PJI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Shaker/Stirrer | JRQ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Spinal Muscular Atrophy Newborn Screening Test System | QUE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry | NQL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Test, Biotinidase | NAK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| ß-Galactocerebrosidase (Galc) Newborn Screening Test System | QCM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| ß-Glucocerebrosidase (Gba) Newborn Screening Test System | PQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2022 | K203035 | Eonis SCID-SMA kit | PJI | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| November 9, 2022 | DEN200044 | Eonis SCID-SMA Kit | QUE | Unknown | Perkinelmer, Inc. | accessdata.fda.gov |
| February 7, 2020 | K193103 | NeoBase 2 Non-derivatized MSMS Kit | NQL | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| December 12, 2019 | DEN180056 | GSP Neonatal Creatine Kinase - MM kit | QJE | Unknown | Perkinelmer, Inc. | accessdata.fda.gov |
| November 6, 2019 | K190335 | GSP Neonatal Total Galactose kit | JIA | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| September 4, 2018 | K173568 | NeoBase 2 Non-derivatized MSMS Kit | NQL | Substantially Equivalent | Wallac Oy, Subsidiary of Perkinelmer, Inc. | accessdata.fda.gov |
| July 18, 2018 | K173829 | NeoLSD MSMS kit | PQW | Substantially Equivalent | Wallac Oy, A Subsidiary of Perkinelmer | accessdata.fda.gov |
| December 15, 2014 | DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | PJI | Unknown | Wallac OY | accessdata.fda.gov |
| November 14, 2013 | K131284 | GSP NEONATAL BIOTINIDASE KIT | NAK | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| June 10, 2011 | K110274 | AUTODELFIA NEONATAL IRT KIT | JNO | Substantially Equivalent | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | accessdata.fda.gov |
| April 22, 2011 | K103484 | GSP NEONATAL THYROXINE (T4) | KLI | Substantially Equivalent | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | accessdata.fda.gov |
| December 16, 2010 | K102419 | GSP NEONATAL IRT KIT (3306-001U) | JNO | Substantially Equivalent | Wallac Oy, Subsidiary of Perkinelmer | accessdata.fda.gov |
| August 23, 2010 | K093916 | NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U | NQL | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| July 23, 2010 | K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | JLX | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| June 11, 2010 | K100101 | GSP NEONATALGALT KIT, MODEL 3303-001U | KQP | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| March 5, 2010 | K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | NAK | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| September 3, 2009 | K090846 | GSP INSTRUMENT AND GSP NEONATAL HTSH KIT | JLW | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| July 9, 2009 | K083130 | NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 | NQL | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| April 16, 2009 | K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | JLX | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| August 7, 2008 | K071649 | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | JIA | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| March 8, 2006 | K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | GKA | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| January 26, 1996 | K943547 | PHENYLALANINE TEST KIT | JNB | Substantially Equivalent | Isolab, Inc. | accessdata.fda.gov |
| September 21, 1995 | K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | JJT | Substantially Equivalent | Isolab, Inc. | accessdata.fda.gov |
| March 10, 1995 | K943416 | DELFIA NEONATAL THYROXINE KIT | CDX | Substantially Equivalent | Wallac OY | accessdata.fda.gov |
| February 21, 1991 | K905710 | PHARMACIA DELFIA NEONATAL HTSH KIT | JLW | Substantially Equivalent | Pharmacia, Inc. | accessdata.fda.gov |
| July 11, 1986 | K862044 | DELFIA (TM) HCG KIT | JHJ | Substantially Equivalent | Lkb Instruments, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 31, 1998 | P970037 | AUTODELFIA HAFP TEST KIT | LOK | 12 | August 11, 2021 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 18, 2026 | 99065 | Class II | Ongoing | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE. | Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results. | accessdata.fda.gov |
| January 10, 2019 | 82064 | Class II | Ongoing | DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum. | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. | accessdata.fda.gov |
| November 17, 2017 | 79421 | Class II | Terminated | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and de | Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results. | accessdata.fda.gov |
| November 2, 2017 | 79303 | Class II | Terminated | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)0643814729 | There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials. | accessdata.fda.gov |
| September 25, 2017 | 79198 | Class III | Terminated | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Produ | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results. | accessdata.fda.gov |
| March 7, 2017 | 76648 | Class II | Terminated | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. | Potential for errors in patient results generated by the Specimen Gate Laboratory Software. | accessdata.fda.gov |
| January 5, 2017 | 76165 | Class II | Terminated | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells o | accessdata.fda.gov |
| August 24, 2015 | 72013 | Class II | Terminated | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. | It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. The analytical test result value would be correct but the interpretation of the test result value would be incorrect. | accessdata.fda.gov |
| January 9, 2012 | 61031 | Not yet classified | Terminated | Perkin Elmer Genetic Screening Processor (GSP) Product code: 2021-0010. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. | GSP instruments with defective washer modules may cause a false negative screening result being reported for T4, TSH and IRT. For 17-OHP, a false positive result may be generated if the failure occurs for a normal sample. | accessdata.fda.gov |
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Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.