Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Utak Laboratories Inc with 24 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 20, 2020: Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the labe….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 20, 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control Class III · The product has an incorrect reference value for cadmium and an incorrect expected range. | Device recalls |
| Nov 2, 1994 | TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROLK943422 · DIF | 510(k) clearances |
| Apr 12, 1991 | UTAK LABORATORIES TOXICOLOGY CONTROLK903061 · LAS | 510(k) clearances |
| Oct 6, 1988 | TRACE ELEMENTS SERUM TOXICOLOGY CONTROLK883147 · JJY | 510(k) clearances |
| Nov 13, 1986 | BENZODIAZEPINES TOXICOLOGY CONTROLK862418 · LAS | 510(k) clearances |
| Nov 13, 1986 | SERUM VANCOMYCIN TOXICOLOGY CONTROLK862419 · LAS | 510(k) clearances |
| Nov 5, 1986 | SERUM CLONAZEPAM TOXICOLOGY CONTROLK862421 · LAS | 510(k) clearances |
| Aug 4, 1986 | UTAK-STABBS TOXICOLOGY CONTROLK862420 · JJY | 510(k) clearances |
| Jul 28, 1983 | TRICYCLIC ANTIDEPRESSANTSK831736 · DIF | 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
