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 Bio-RadLabelled by claude-sonnet-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 Kallestad Laboratories with 92 510(k) clearances. The most recent is a 510(k) clearance dated Dec 3, 1986: PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM.
| Dec 3, 1986 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMK863681 · LJP | 510(k) clearances |
| Oct 22, 1986 | PATHFINDER ROTAVIRUS CHEMILUMINESCENTK862917 · LIQ | 510(k) clearances |
| Oct 10, 1986 | PATHFINDER(TM) SPECIMEN COLLECTION KITK863682 · JSM | 510(k) clearances |
| Sep 29, 1986 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSK862743 · GQG | 510(k) clearances |
| Aug 6, 1986 | KALLESTAD SM/RNP TEST REAGENTK862313 · LKJ | 510(k) clearances |
| Jul 29, 1986 | KALLESTAD SSA/SSB ENA TEST REAGENTSK862710 · LLL | 510(k) clearances |
| Mar 14, 1986 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET AK855014 · JIX | 510(k) clearances |
| Feb 28, 1986 | QUANTIMETRIC PLUS IGM REAGENT KITK855010 · DFT | 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
