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 15, 2026, FDA's public records list Wien Laboratories with 13 510(k) clearances. The most recent is a 510(k) clearance dated Aug 12, 1991: SHBG.
| Aug 12, 1991 | SHBGK912850 · CDZ | 510(k) clearances |
| Feb 4, 1984 | PROGESTERONE TEST SET 125I 17-OHK834246 · JLX | 510(k) clearances |
| Sep 12, 1983 | ANDROSTENEDIONE TEST SET 125IK832452 · CIZ | 510(k) clearances |
| Nov 29, 1982 | 125 I-DEHYDROEPIANDROSTERONE SULFATEK823200 · JKC | 510(k) clearances |
| Jun 14, 1982 | DOXEPIN TRI-CY TEST SETK821652 · LFG | 510(k) clearances |
| Jun 14, 1982 | PROTRIPTYLINE TRI-CY TEST SETK821653 · LFG | 510(k) clearances |
| Dec 11, 1980 | 125I-TESTOSTERONE TEST SETK802728 · CDZ | 510(k) clearances |
| Oct 30, 1979 | DHEA-SULFATE TEST SETK792041 · JKC | 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
