Hemometrix
Country not established
- Devices
- 7
What Hemometrix makes
Hemometrix manufactures liquid control sera and platelet retention (adhesion) columns for laboratory testing. The liquid control sera include gentamicin, tobramycin, and amikacin, used to verify the accuracy of antimicrobial assays. Platelet retention columns are designed for platelet function analysis in hematology diagnostics.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their authorised status for commercial distribution in the US.
Catalogue
Gentamicin Liquid Control Serum Ref K792262
Regimes: 510(k) Registry: 510(k)Platelet Retention (Adhesion) Columns Ref K800037
Regimes: 510(k) Registry: 510(k)Tobramycin Liquid Control Serum Ref K792264
Regimes: 510(k) Registry: 510(k)Amikacin Control Serum Ref K792259
Regimes: 510(k) Registry: 510(k)Amikacin Liquid Control Serum Ref K792260
Regimes: 510(k) Registry: 510(k)Gentamicin Control Serum Ref K792261
Regimes: 510(k) Registry: 510(k)Tobramycin Control Serum Ref K792263
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hemometrix have in the registry?
The registry currently lists 7 devices for Hemometrix. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemometrix's devices?
Among its 7 most recently registered devices, Hemometrix has devices listed in FDA 510(k) (7 devices).
What risk classes do Hemometrix's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Hemometrix's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemometrix in the registry?
The most recently registered devices listed for Hemometrix include GENTAMICIN LIQUID CONTROL SERUM, PLATELET RETENTION (ADHESION) COLUMNS, TOBRAMYCIN LIQUID CONTROL SERUM and AMIKACIN CONTROL SERUM.