FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Shared Systems with 5 510(k) clearances. The most recent is a 510(k) clearance dated Jan 2, 1998: CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800.
| Jan 2, 1998 | CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800K973457 · GMZ | 510(k) clearances |
| Dec 13, 1995 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEMK955042 · DCN | 510(k) clearances |
| Oct 17, 1995 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMK950073 · GSA | 510(k) clearances |
| Aug 15, 1995 | CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEMK953261 · DHR | 510(k) clearances |
| Aug 20, 1992 | MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEMK920212 · LJZ | 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
