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., part of DiaSorinLabelled 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 15, 2026, FDA's public records list INCSTAR with 58 510(k) clearances. The most recent is a 510(k) clearance dated May 1, 1997: INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY.
| May 1, 1997 | INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAYK963289 · LGD | 510(k) clearances |
| Dec 16, 1996 | INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)K963296 · LGD | 510(k) clearances |
| Dec 16, 1996 | INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)K963297 · LGD | 510(k) clearances |
| Oct 24, 1996 | INCSTAR RUBELLA IGG FAST ELISA ASSAYK960358 · LFX | 510(k) clearances |
| Oct 24, 1996 | INCSTAR RUBELLA IGG ELISA ASSAYK960367 · LFX | 510(k) clearances |
| Oct 17, 1996 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530K960434 · LFZ | 510(k) clearances |
| Sep 25, 1996 | INCSTAR 25-HYDROXYVITMIN D 1251 RIAK953567 · MRG | 510(k) clearances |
| Jul 24, 1996 | INCSTAR HSZ I/II IGG ELISA ASSAYK955363 · IGC | 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
