Medical device 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 Hypoguard USA with 9 510(k) clearances. The most recent is a 510(k) clearance dated Mar 28, 2006: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001.
| Mar 28, 2006 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001K053079 · CGA | 510(k) clearances |
| Oct 4, 2005 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002K051514 · NBW | 510(k) clearances |
| Mar 25, 2005 | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100K041881 · CGA | 510(k) clearances |
| Mar 2, 2004 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)K033851 · JIL | 510(k) clearances |
| May 22, 2003 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMK031388 · CGA | 510(k) clearances |
| Mar 28, 2003 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEMK024347 · CGA | 510(k) clearances |
| Oct 11, 2002 | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020K022545 · NBW | 510(k) clearances |
| Feb 12, 2002 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEMK020232 · CGA | 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
