FDA applicant
Hemometrix
FDA records 7 decisions for Hemometrix (Mchenry, IL) from 1979 to 1980: 7 510(k) clearances. Most are in product codes LAS (Drug Specific Control Materials) and JBZ (Study, Platelet Adhesive). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hemometrix’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hemometrix since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hemometrix’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report