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 AbbottLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list i-STAT Corporation with 21 510(k) clearances. The most recent is a 510(k) clearance dated Jul 21, 2006: I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP).
| Date | Record | Source |
|---|---|---|
| Jul 21, 2006 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)K053597 · NBC | 510(k) clearances |
| Jan 13, 2006 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeK053110 · JGS | 510(k) clearances |
| Dec 15, 2005 | I-STAT CREATINE KINASE MB (CK-MB)K051433 · MYT | 510(k) clearances |
| Oct 7, 2003 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SETK031873 · JJX | 510(k) clearances |
| Sep 8, 2003 | I-STAT KAOLIN ACT TESTK023582 · JBP | 510(k) clearances |
| Sep 2, 2003 | I-STAT CARDIAC TROPONIN (CTNI) TESTK031739 · MMI | 510(k) clearances |
| May 14, 2002 | I-STAT PROTHROMBIN TIME TESTK020355 · GJS | 510(k) clearances |
| Aug 20, 2001 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZERK012478 · CHL | 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
