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.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Akers Biosciences and its 1 subsidiaries with 8 510(k) clearances. The most recent is a 510(k) clearance dated Jan 12, 2011: BREATHSCN PRO.
| Jan 12, 2011 | BREATHSCN PROK102338 · DJZ | 510(k) clearances |
| Dec 18, 2006 | BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMSK062971 · DJZ | 510(k) clearances |
| Apr 28, 2006 | BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORSK060761 · DJZ | 510(k) clearances |
| Jan 4, 2006 | HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANELK052697 · GGN | 510(k) clearances |
| Mar 4, 2005 | MODIFICATION TO: INSTAREAD LITHIUM SYSTEMK050338 · JIH | 510(k) clearances |
| May 28, 2004 | HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAYK040293 · LCO | 510(k) clearances |
| Dec 19, 2003 | INSTAREAD LITHIUM SYSTEMK031579 · JIH | 510(k) clearances |
| Sep 17, 2003 | AKERS LABORATORIES INC. BLOOD CELL SEPARATORK030815 · JKA | 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
