Awareness Technology, Inc.
United StatesFDA 510(k) applicant, unverified FDA FEI 1036223
- Devices
- 18
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Awareness Technology, Inc. makes
Awareness Technology, Inc. manufactures photometric analyzers, including multi-filter photometers and single-filter models like the SPECTRA 1, for biochemical and clinical chemistry applications. It also produces hemoglobin analyzers, colorimeters such as the AP1, and automated systems for dye-based assays, including DRI-DYE CHECK STRIPS and dye check strips for specific wavelength ranges. The company’s portfolio includes ELISA instruments, microassay systems like the PROJECT 300 BP-12, and automated testing platforms for serological and allergy diagnostics.
The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. Awareness Technology, Inc. is headquartered in the US.
Catalogue
Search and filter all 18 devicesCompany details
- FDA FEI number
- 1036223
- Address
- 1935 S.W. MARTIN HWY., PALM CITY, FL, 34990
- Website
- www.awaretech.com
- linkedin.com/company/1687018
- [email protected]
Frequently asked questions
How many devices does Awareness Technology, Inc. have in the registry?
The registry currently lists 18 devices for Awareness Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Awareness Technology, Inc.'s devices?
Among its 18 most recently registered devices, Awareness Technology, Inc. has devices listed in FDA 510(k) (18 devices).
What risk classes do Awareness Technology, Inc.'s devices fall under?
Among its 18 most recently registered devices, the classes recorded for Awareness Technology, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Awareness Technology, Inc. in the registry?
The most recently registered devices listed for Awareness Technology, Inc. include FOCUS-GHB, SMART ALEX II MULTI-FILTER PHOTOMETER, CHEMWELL, ALSO KNOWN AS PROJECT 2900 and HEMOGLOBIN ANALYZER.