Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list PerkinElmer and its 4 subsidiaries with 46 510(k) clearances and 32 device recalls. 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, PerkinElmer and its 4 subsidiaries
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 |
| Nov 9, 2022 | Eonis SCID-SMA kitK203035 · PJI | 510(k) clearances |
| Nov 9, 2022 | Eonis SCID-SMA KitDEN200044 · QUE | 510(k) clearances |
| Feb 7, 2020 | NeoBase 2 Non-derivatized MSMS KitK193103 · NQL | 510(k) clearances |
| Dec 12, 2019 | GSP Neonatal Creatine Kinase - MM kitDEN180056 · QJE | 510(k) clearances |
| Nov 6, 2019 | GSP Neonatal Total Galactose kitK190335 · JIA | 510(k) clearances |
| May 3, 2019 | NeoLSD MSMS KitK190266 · PQW | 510(k) clearances |
| Sep 4, 2018 | NeoBase 2 Non-derivatized MSMS KitK173568 · NQL | 510(k) clearances |
| Jul 18, 2018 | NeoLSD MSMS kitK173829 · PQW | 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
