This page includes the latest FDA filings for Wallac Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Device Company | Device | Date |
|---|---|---|
| Wallac Oy | Iduronate 2-sulfatase S&IS 4400-0010 | 2023-04-25 |
| Wallac Oy | DBS Controls M2 3255-0010 | 2023-04-25 |
| Wallac Oy | Buffer M 4402-0010 | 2023-04-25 |
| Wallac Oy | RESOLVE Hb FACS Control kit 3412-0010 | 2023-04-25 |
| Wallac Oy | Qsight 225 MD Screening System 2040-0030 | 2023-04-06 |
| Wallac Oy | Qsight 210 MD Screening System 2040-0010 | 2023-04-06 |
| Wallac Oy | Eonis Analysis software 5020-1000 | 2022-12-12 |
| Wallac Oy | Eonis SCID-SMA kit 3242-001U | 2022-12-08 |
| Wallac Oy | Eonis SCID-SMA kit 3241-001U | 2022-12-08 |
| Wallac Oy | Eonis DNA Extraction kit 3240-001U | 2022-12-08 |
| Wallac Oy | EVOYA Platform 5021-1000 | 2022-12-07 |
| Wallac Oy | AutoDELFIA Automatic Immunoassay System 1235-5220 | 2022-08-19 |
| Wallac Oy | AutoDELFIA Automatic Immunoassay System 1235-5110 | 2022-08-19 |
| Wallac Oy | GSP Neonatal Total Galactose kit 3309-002U | 2021-06-14 |
| Wallac Oy | GSP Neonatal Creatine Kinase -MM kit 3311-001U | 2021-06-14 |
| Wallac Oy | DELFIA Platewash 1296-026 | 2021-06-14 |
| Wallac Oy | NeoBase 2 Succinylacetone Assay Solution 3046-0010 | 2020-04-30 |
| Wallac Oy | NeoBase 2 Non-derivatized Assay Solutions 3045-0010 | 2020-04-30 |
| Wallac Oy | RESOLVE Systems Hb Elution Solution 3025-0010 | 2019-05-28 |
| Wallac Oy | RESOLVE Systems Hb Elution Solution 3024-0010 | 2019-05-28 |
| Wallac Oy | RESOLVE Systems Neonatal Hemoglobin Kit FR-9400 | 2019-05-28 |
| Wallac Oy | RESOLVE Systems JB-2 Staining System FR-9367 | 2019-05-28 |
| Wallac Oy | RESOLVE Systems Neonatal Hemoglobin Kit FR-9360 | 2019-05-28 |
| Wallac Oy | RESOLVE Systems Hemoglobin Kit FR-9120 | 2019-05-28 |
| Wallac Oy | Panthera-Puncher 9 2081-0010 | 2019-05-08 |
| Wallac Oy | Wallac DBS Puncher 1296-071 | 2019-05-08 |
| Wallac Oy | VICTOR EnLite 1420-0230 | 2019-03-27 |
| Wallac Oy | VICTOR EnLite 1420-0220 | 2019-03-27 |
| Wallac Oy | Specimen Gate Laboratory 5002-0180 | 2019-03-27 |
| Wallac Oy | VICTOR2 D 1420-021 | 2019-03-27 |
| Wallac Oy | VICTOR2 D 1420-020 | 2019-03-27 |
| Wallac Oy | AutoDELFIA hAFP kit B079-212 | 2019-03-21 |
| Wallac Oy | AutoDELFIA hAFP Kit B079-201 | 2019-03-21 |
| Wallac Oy | NeoBase 2 Non-derivatized MSMS kit 3044-001U | 2019-03-11 |
| Wallac Oy | chemagic 360-D 2024-0010 | 2019-03-11 |
| Wallac Oy | chemagic Prepito -D 2022-0020 | 2019-03-11 |
| Wallac Oy | Screening Center 5002-0500 | 2019-03-11 |
| Wallac Oy | TriNEST 1296-0050 | 2019-03-11 |
| Wallac Oy | PatientCare 5002-0130 | 2019-03-11 |
| Wallac Oy | Wallac Plate Shake 1296-004 | 2019-03-11 |
| Wallac Oy | Migele Gel Electrophoresis Unit 2118-0010 | 2018-12-31 |
| Wallac Oy | NeoLSD MSMS kit 3093-001U | 2018-12-31 |
| Wallac Oy | MSMS Workstation 5002-0540 | 2018-12-31 |
| Wallac Oy | AutoDELFIA Inhibin A kit Level Calibrators B064-112-P2 | 2018-12-24 |
| Wallac Oy | AutoDELFIA Unconjugated Estriol (uE3) kit B083-C01 | 2018-12-18 |
| Wallac Oy | AutoDELFIA Unconjugated Estriol (uE3) kit B083-212 | 2018-12-18 |
| Wallac Oy | AutoDELFIA Unconjugated Estriol (uE3) kit B095-112 | 2018-12-17 |
| Wallac Oy | AutoDELFIA Unconjugated Estriol (uE3) kit B095-101U | 2018-12-17 |
| Wallac Oy | GSP Neonatal 17α-OH-progesterone kit 3305-001U | 2018-12-17 |
| Wallac Oy | AutoDELFIA Neonatal 17α-OH-progesterone kit B024-104 | 2018-12-17 |
| Wallac Oy | AutoDELFIA Neonatal 17α-OH-progesterone kit B024-112 | 2018-12-17 |
| Wallac Oy | AutoDELFIA Neonatal 17α-OH-progesterone kit B024-01C | 2018-12-17 |
| Wallac Oy | DELFIA Diluent 3 4022-0010 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent 3 4021-0010 | 2018-12-17 |
| Wallac Oy | DELFIA Wash Concentrate 4010-0010 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent II B138-100 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent II B132-100 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent II B131-100 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent I B128-100 | 2018-12-17 |
| Wallac Oy | DELFIA Diluent I B127-100 | 2018-12-17 |
| Wallac Oy | DELFIA Enhancement Solution B118-100 | 2018-12-17 |
| Wallac Oy | DELFIA Wash Concentrate B117-100 | 2018-12-17 |
| Wallac Oy | DELFIA Wash Concentrate 1244-114 | 2018-12-17 |
| Wallac Oy | DELFIA Enhancement Solution 1244-105 | 2018-12-17 |
| Wallac Oy | DELFIA Enhancement Solution 1244-104 | 2018-12-17 |
| Wallac Oy | NeoBase Non-derivatized MSMS kit 3040-001U | 2018-12-13 |
| Wallac Oy | NeoBase Succinylacetone Assay Solution 3042-0020 | 2018-12-13 |
| Wallac Oy | NeoBase Non-derivatized Assay Solutions 3041-0020 | 2018-12-13 |
| Wallac Oy | EnLite Neonatal TREC kit 3403-001U | 2018-07-06 |
| Wallac Oy | EnLite Neonatal TREC kit 3402-001U | 2018-07-06 |
| Wallac Oy | EnLite Neonatal TREC kit 3401-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal Biotinidase kit 3307-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal Total Galactose Kit 3309-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal GALT kit 3303-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal IRT kit 3306-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal Thyroxine (T4) kit 3302-001U | 2018-07-06 |
| Wallac Oy | GSP Neonatal hTSH kit 3301-001U | 2018-07-06 |
| Wallac Oy | Genetic Screening Processor 2021-0010 | 2018-07-06 |
| Wallac Oy | AutoDELFIA Neonatal IRT kit B005-204 | 2018-07-06 |
| Wallac Oy | AutoDELFIA Neonatal IRT kit B005-212 | 2018-07-06 |
| Wallac Oy | Neonatal Biotinidase kit 3018-001B | 2018-07-06 |
| Wallac Oy | Neonatal Biotinidase kit 3018-0010 | 2018-07-06 |
| Wallac Oy | NeoGram Derivatized Assay Solutions 3030-0020 | 2018-07-06 |
| Wallac Oy | NeoGram Amino Acids and Acylcarnitines Tandem Mass 3026-0030 | 2018-07-06 |
| Wallac Oy | Neonatal Total Galactose kit 3029-0010 | 2018-07-06 |
| Wallac Oy | Neonatal Phenylalanine kit NP-4000 | 2018-07-06 |
| Wallac Oy | Neonatal Phenylalanine kit NP-1000 | 2018-07-06 |
| Wallac Oy | Neonatal GALT kit NG-4100 | 2018-07-06 |
| Wallac Oy | Neonatal GALT kit NG-1100 | 2018-07-06 |
| Wallac Oy | AutoDELFIA Neonatal hTSH kit B032-312 | 2018-03-29 |
| Wallac Oy | DELFIA Neonatal hTSH kit A032-310 | 2018-03-29 |
| Wallac Oy | AutoDELFIA Sample Processor 1297-014 | 2018-03-29 |
| Wallac Oy | AutoDELFIA Plate Processor 1235-001 | 2018-03-29 |
| Wallac Oy | AutoDELFIA Neonatal Thyroxine (T4) kit B065-112 | 2018-03-29 |
| Wallac Oy | AutoDELFIA hCG kit B007-112 | 2018-03-29 |
| Wallac Oy | AutoDELFIA hCG kit B007-101 | 2018-03-29 |
| Wallac Oy | DELFIA Neonatal Thyroxine (T4) kit A065-110 | 2018-03-29 |
| Wallac Oy | DELFIA hLH Spec kit A031-101 | 2018-03-29 |
| Wallac Oy | DELFIA hFSH kit A017-201 | 2018-03-29 |
| Wallac Oy | DELFIA hCG kit A007-101 | 2018-03-29 |
WALLAC OY | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | 2014-12-15 |
WALLAC OY | GSP NEONATAL BIOTINIDASE KIT | 2013-11-14 |
WALLAC OY | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | 2010-07-23 |
WALLAC OY | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | 2009-04-16 |
WALLAC OY | NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B | 2008-08-07 |
WALLAC OY | AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 | 2008-04-14 |
WALLAC OY | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | 2006-03-08 |
WALLAC OY | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | 2005-07-11 |
WALLAC OY | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | 2004-09-30 |
WALLAC OY | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | 2004-09-30 |
WALLAC OY | DELFIA NEONATAL IRT KIT, MODEL A005-110 | 2001-02-14 |
WALLAC OY | AUTODELFIA NEONATAL IRT KIT, MODEL B005-112 | 2001-02-12 |
WALLAC OY | DELFIA NEONATAL IRT KIT | 2000-06-09 |
WALLAC OY | DELFIA NEONATAL THYROXINE KIT | 1995-03-10 |
WALLAC OY | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT | 1994-12-09 |
WALLAC OY | DELFIA SHBG KIT | 1994-09-06 |
WALLAC OY | AUTO DELFIA | 1994-05-23 |
WALLAC OY | DELFIA TESTTOSTERONE KIT | 1993-08-03 |
WALLAC OY | DELFIA CORTISOL KIT | 1993-07-27 |
WALLAC OY | DELFIA(R) HGH KIT | 1993-05-11 |
WALLAC OY | DELFIA DIGOXIN KIT | 1992-12-17 |
WALLAC OY | DELFIA HTSH ULTRA KIT | 1992-11-30 |