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 14, 2026, FDA's public records list Simplicity Diagnostics with 5 510(k) clearances. The most recent is a 510(k) clearance dated Mar 10, 1997: TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL.
| Mar 10, 1997 | TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLK970100 · MJX | 510(k) clearances |
| Oct 5, 1992 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROLK922726 · KTN | 510(k) clearances |
| Oct 5, 1992 | TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROLK922725 · DHR | 510(k) clearances |
| Oct 5, 1992 | TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROLK922722 · DCK | 510(k) clearances |
| Sep 18, 1992 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLK922723 · GTQ | 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
