Statspin Technologies
Country not established
- Devices
- 5
What Statspin Technologies makes
Statspin Technologies manufactures laboratory reagents and diagnostic devices for blood and plasma analysis, including the LIPOCLEAR Lipemia Clearing Reagent for improving sample clarity in lipid testing, as well as automated sampling and hematocrit measurement tools like the STATSPIN Statsampler and Mini-Plasma system. Their product line also includes the STATSPIN Micro-Hematocrit Reader, designed for use with 75mm tubes, and the STATSPIN Statsampler for automated sample processing in clinical settings.
The company’s devices fall under FDA Class II regulation and are listed via the 510(k) pathway, indicating they are subject to premarket notification requirements. These products are intended for use in the United States, where Statspin Technologies is based.
Catalogue
Lipoclear Lipemia Clearing Reagent Ref K884807
Regimes: 510(k) Registry: 510(k)Statspin Statsampler Ref K896206
Regimes: 510(k) Registry: 510(k)Statspin Mini-Plasma Ref K893613
Regimes: 510(k) Registry: 510(k)Critspin Micro-Hematocrit Ref K920759
Regimes: 510(k) Registry: 510(k)Statspin Micro-Hematocrit Reader For 75mm Tubes Ref K903698
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Statspin Technologies have in the registry?
The registry currently lists 5 devices for Statspin Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Statspin Technologies's devices?
Among its 5 most recently registered devices, Statspin Technologies has devices listed in FDA 510(k) (5 devices).
What risk classes do Statspin Technologies's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Statspin Technologies's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Statspin Technologies in the registry?
The most recently registered devices listed for Statspin Technologies include LIPOCLEAR LIPEMIA CLEARING REAGENT, STATSPIN STATSAMPLER, STATSPIN MINI-PLASMA and CRITSPIN MICRO-HEMATOCRIT.