Medical device makerLabelled 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 Intersect Systems, Inc. with 21 510(k) clearances. The most recent is a 510(k) clearance dated Jul 17, 2002: ALBUMIN REAGENT.
| Jul 17, 2002 | ALBUMIN REAGENTK021636 · CJW | 510(k) clearances |
| Aug 27, 2001 | DIRECT BILIRUBIN REAGENTK011972 · CIG | 510(k) clearances |
| Jul 25, 2001 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK011692 · LPS | 510(k) clearances |
| Feb 20, 2001 | TOTAL BILIRUBIN REAGENTK003892 · CIG | 510(k) clearances |
| Jan 6, 1999 | DUAL VIAL CREATININE REAGENTK983937 · CGX | 510(k) clearances |
| Feb 13, 1998 | CK-NAC REAGENTK974833 · CGS | 510(k) clearances |
| Sep 14, 1994 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENTK941807 · CHG | 510(k) clearances |
| Jan 31, 1994 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENTK932888 · JFJ | 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
