Biosite
Diagnostics makerAI in United StatesAI, part of AbbottAI. FDA records under its name, each linked to the record.
- 510(k) clearances: 45
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jun 11, 2010 | INRATIO/INRATIO2 TEST STRIPSK092987 · GJS | 510(k) clearances |
| Apr 19, 2010 | ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPK092048 · DJR | 510(k) clearances |
| Nov 13, 2009 | TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SETK093032 · JJY | 510(k) clearances |
| Jun 6, 2008 | TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELSK080269 · NBC | 510(k) clearances |
| Dec 7, 2007 | TRIAGE TOTAL CONTROLS 5, TRIAGE TOTAL CALIBRATION VERIFICATION 5K072892 · JJY | 510(k) clearances |
| Mar 1, 2007 | TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLSK062840 · GGN | 510(k) clearances |
| Jan 29, 2007 | TRIAGE PROTEIN C TESTK062530 · GGP | 510(k) clearances |
| Jul 10, 2006 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414K060788 · DIF | 510(k) clearances |
Names and Identifiers
- Appears as
- Website
- abbott.com
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