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 GSK. FDA records under its name, each linked to the record. See the GSK group view.
As of Nov 13, 2026, FDA's public records list SmithKline Diagnostics, Inc. with 42 510(k) clearances. The most recent is a 510(k) clearance dated Nov 6, 1996: FLEXSURE OBT.
| Date | Record | Source |
|---|---|---|
| Nov 6, 1996 | FLEXSURE OBTK961062 · KHE | 510(k) clearances |
| Jun 7, 1996 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)K960183 · LYR | 510(k) clearances |
| May 18, 1994 | FLEXSURE HPK934863 · LYR | 510(k) clearances |
| May 23, 1988 | HEMOCCULT SENSITIVE TESTK880499 · KHE | 510(k) clearances |
| Mar 1, 1988 | (SKD) CHOLESTEROL TEST KITK875131 · CHH | 510(k) clearances |
| Dec 9, 1986 | HEMOCCULT WIPE TESTK862849 · KHE | 510(k) clearances |
| Mar 5, 1986 | SKD ELECTROCHEMICAL SYSTEM (ECS)K854723 · CEM | 510(k) clearances |
| Jul 24, 1985 | RAPID DIRECT STREP A LATEX AGGLUTINATION TESTK852841 · GTZ | 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
