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 RocheLabelled 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. See the Roche group view.
As of Nov 13, 2026, FDA's public records list Biotrack with 16 510(k) clearances. The most recent is a 510(k) clearance dated Dec 29, 1993: BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS.
| Date | Record | Source |
|---|---|---|
| Dec 29, 1993 | BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLSK934062 · DIF | 510(k) clearances |
| Dec 29, 1993 | BIOTRACK VALPROIC ACID TEST CARTRIDGEK934061 · LEG | 510(k) clearances |
| Aug 5, 1992 | BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROLK920525 · DIS | 510(k) clearances |
| Jul 23, 1992 | BIOTRACK PHENYTOIN TEST CARTRIDGEK915755 · DIP | 510(k) clearances |
| Jul 23, 1992 | BIOTRACK CARBAMAZEPINE TEST CARTRIDGEK915756 · KLT | 510(k) clearances |
| Sep 17, 1990 | BIOTRACK THEOPHYLLINE QUALITY CONTROLSK903924 · LAW | 510(k) clearances |
| May 30, 1990 | BIOTRACK THEOPHYLLINE TEST CARTRIDGEK900373 · KLS | 510(k) clearances |
| Feb 23, 1990 | BIOTRACK IMMUNOCHEMISTRY MONITORK900372 · JJQ | 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
