Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of PerkinElmerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Wallac Oy with 28 510(k) clearances and 1 device recall. The most recent is a device recall dated May 18, 2026: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Us….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 18, 2026 | GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATClass II · Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and conse | Device recalls |
| Sep 4, 2018 | NeoBase 2 Non-derivatized MSMS KitK173568 · NQL | 510(k) clearances |
| Jul 18, 2018 | NeoLSD MSMS kitK173829 · PQW | 510(k) clearances |
| Dec 15, 2014 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEMDEN140010 · PJI | 510(k) clearances |
| Apr 28, 2014 | GSP NEONATAL TOTAL GALACTOSE KITK133652 · JIA | 510(k) clearances |
| Nov 14, 2013 | GSP NEONATAL BIOTINIDASE KITK131284 · NAK | 510(k) clearances |
| Jun 10, 2011 | AUTODELFIA NEONATAL IRT KITK110274 · JNO | 510(k) clearances |
| Apr 22, 2011 | GSP NEONATAL THYROXINE (T4)K103484 · KLI | 510(k) clearances |
| Dec 16, 2010 | GSP NEONATAL IRT KIT (3306-001U)K102419 · JNO | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
