Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 4 companies' records, each linked to the record.
As of Nov 14, 2026, FDA's public records list Labcorp and its 4 subsidiaries with 30 510(k) clearances and 2 warning letters. The most recent is a warning letter dated Oct 25, 2022: Warning letter: Biologics.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Labcorp and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 25, 2022 | Warning letter: BiologicsCBER | Warning letters |
| Feb 10, 2022 | Warning letter: BiologicsCBER | Warning letters |
| Oct 22, 2014 | VANTERA CLINICAL ANALYZERK133849 · NSU | 510(k) clearances |
| Jun 13, 2014 | IMPACT DX FACTOR V LEIDEN AND FACTOR II GENOTYPING TESTK132978 · PHJ | 510(k) clearances |
| Aug 30, 2012 | VANTERA CLINICAL ANALYZERK113830 · CDT | 510(k) clearances |
| Sep 27, 2011 | NMR LIPOPROFILE (R) TEST AND NMR PROFILERK111516 · LBS | 510(k) clearances |
| Jul 23, 2008 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSK063841 · MRR | 510(k) clearances |
| May 22, 1996 | LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTUREK951440 · KIR | 510(k) clearances |
| May 22, 1996 | NCI-H292 CELL CULTUREK951461 · KIR | 510(k) clearances |
| May 13, 1987 | BUFFALO GREEN MONKEY KIDNEY CELLSK871613 · KIR | 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
