Diagnostics 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 15, 2026, FDA's public records list Ind Diagnostic with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 17, 2012: IND URINARY TRACT INFECTION (UTI) TEST STRIPS.
| Apr 17, 2012 | IND URINARY TRACT INFECTION (UTI) TEST STRIPSK103037 · NGJ | 510(k) clearances |
| Jul 19, 2010 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10K100031 · KHE | 510(k) clearances |
| Mar 1, 2007 | URINE CHEMISTRY ANALYZER UR-50K063390 · JIL | 510(k) clearances |
| Aug 7, 2006 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COCK060810 · DKZ | 510(k) clearances |
| Dec 16, 2005 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.K052694 · JHI | 510(k) clearances |
| Nov 30, 2005 | ONE STEP FSH MENOPAUSAL TESTK052662 · CGJ | 510(k) clearances |
| May 16, 2005 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMATK050741 · JHI | 510(k) clearances |
| Jan 3, 2003 | CASSETTE/URINE HCGK023638 · LCX | 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
