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 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Streck with 37 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Mar 27, 2026: MDx-Chex for BCP.
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.
| Mar 27, 2026 | MDx-Chex for BCPK260041 · PMN | 510(k) clearances |
| Mar 23, 2026 | MDx-Chex for BCNK254166 · PMN | 510(k) clearances |
| Mar 17, 2026 | MDx-Chex for BCYK254167 · PMN | 510(k) clearances |
| Jul 26, 2024 | Cell-Free DNA BCTK231776 · QMA | 510(k) clearances |
| Jul 27, 2023 | MDx-Chex for BC-GNK231223 · PMN | 510(k) clearances |
| Jul 27, 2023 | MDx-Chex for BC-GPK231221 · PMN | 510(k) clearances |
| Jan 19, 2022 | MDx-Chex for BCID2K212576 · PMN | 510(k) clearances |
| Aug 7, 2020 | Cell-Free DNA BCTDEN200001 · QMA | 510(k) clearances |
| Feb 23, 2017 | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 21355Class II · Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. | Device recalls |
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
