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 SeragenLabelled 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 Seragen Diagnostics with 20 510(k) clearances. The most recent is a 510(k) clearance dated Aug 19, 1987: VIVID CHLAMYDIA(TM).
| Aug 19, 1987 | VIVID CHLAMYDIA(TM)K872148 · LJC | 510(k) clearances |
| Jul 23, 1985 | QUICK-COUNT HEMATOLOGY CONTROLSK851663 · JPK | 510(k) clearances |
| Jul 22, 1985 | QUICK-CHEM CALIBRATION SETK852260 · JIW | 510(k) clearances |
| Jun 25, 1985 | CK/LD ISOENZYMES CONTROLS(HUMAN)K851520 · JJT | 510(k) clearances |
| May 10, 1985 | LD-1(IMMUNO) SEPARATION SETK851521 · CEX | 510(k) clearances |
| Feb 27, 1985 | QUICK-LYTEK850209 · JGS | 510(k) clearances |
| Feb 4, 1985 | SERATEST ENA(RNP/SM) DETERMINATIONK844743 · LLL | 510(k) clearances |
| Oct 25, 1984 | SERATEST DNA DETERMINATIONK842563 · LKJ | 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
