Harris Mfg. Co.
Country not established
- Devices
- 2
What Harris Mfg. Co. makes
Harris Mfg. Co. manufactures modified low-temperature freezers, including the HLT-80LS-85 model, designed for controlled storage of biological samples and pharmaceuticals at sub-zero temperatures. The company also produces the Harris Model 2000, a specialized freezer unit for laboratory and industrial applications requiring precise temperature regulation.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance for market authorization. These products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Modified Low-Temp. Freezer Model Hlt-80LS-85 Ref K884436
Regimes: 510(k) Registry: 510(k)Harris Model 2000 Ref K921906
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Harris Mfg. Co. have in the registry?
The registry currently lists 2 devices for Harris Mfg. Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Harris Mfg. Co.'s devices?
Among its 2 most recently registered devices, Harris Mfg. Co. has devices listed in FDA 510(k) (2 devices).
What risk classes do Harris Mfg. Co.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Harris Mfg. Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Harris Mfg. Co. in the registry?
The most recently registered devices listed for Harris Mfg. Co. include MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 and HARRIS MODEL 2000.