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 13, 2026, FDA's public records list Kyoto Diagnostics with 11 510(k) clearances. The most recent is a 510(k) clearance dated Jul 25, 1986: ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS.
| Jul 25, 1986 | ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK861733 · JIL | 510(k) clearances |
| Sep 28, 1984 | GLUCOSE AUTO& STAT GA-1120K843003 · CGA | 510(k) clearances |
| Aug 17, 1984 | OSMOTIC PRESSURE AUTO & STAT OM-6010K842750 · JJM | 510(k) clearances |
| Jul 16, 1984 | ATAGO URINE SPECIFIC GRAVITY & SERUMK842168 · JRE | 510(k) clearances |
| May 31, 1984 | KYOTEST UG URINE TEST REAGENT STRIPK841713 · JIL | 510(k) clearances |
| May 31, 1984 | KYOTEST UK URINE TEST REAGENT STRIPK841715 · JIN | 510(k) clearances |
| May 31, 1984 | KYOTEST 2V, URINE TEST REAGENT STRIPK841714 · JIL | 510(k) clearances |
| May 14, 1984 | KYOTEST 8VK840828 · JMT | 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
