Medical device 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 Biotecx Laboratories, Inc. with 15 510(k) clearances. The most recent is a 510(k) clearance dated Feb 3, 1999: OPTICOAT T4 EIA KIT.
| Feb 3, 1999 | OPTICOAT T4 EIA KITK982298 · KLI | 510(k) clearances |
| Dec 22, 1998 | OPTICOAT T3 EIA KITK981824 · CDP | 510(k) clearances |
| Oct 19, 1989 | CORTISOL CLASP-BEAD EIA KITK895407 · CGR | 510(k) clearances |
| Aug 11, 1989 | T3 CLASP-BEAD EIA KITK893620 · CDP | 510(k) clearances |
| May 22, 1989 | T4 CLASP-BEAD EIA KITK892853 · KLI | 510(k) clearances |
| Oct 31, 1988 | TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINEK883765 · KHQ | 510(k) clearances |
| Apr 13, 1987 | PROGESTERONE CLASP RADIOIMMUNOASSAY KITK871211 · JLS | 510(k) clearances |
| Sep 25, 1986 | HPL RIA KITK863188 · JMX | 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
