Data / Medical devices / United States / Awareness Technology, Inc.
Awareness Technology, Inc.: FDA-registered device maker in Palm City, FL, United States, 1 510(k) clearance
Awareness Technology, Inc. is registered with the FDA (registration 1036223) in Palm City, FL, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 27, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1036223
- Address
- 1935 S.W. Martin Hwy., Palm City, FL, United States, 34990
- Owner or operator
- AWARENESS TECHNOLOGY, INC. (1036223)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 7, 1992
- Registered through
- 2026
- Brand names listed
- Autoplex® 2nd Generation ELISA & CLIA Analyzer (Ref IN006-2), Autoplex® 3rd Generation Dual Plate ELISA Analyzer (Ref IN006-3), Autoplex® ELISA & CLIA Analyzer (Ref IN006), CHEMWELL, Immunoassay Plate Washer (Ref IN002), LuMatic® CLIA Analyzer (Ref IN008), NeoEldex® ELISA Analyzer (Ref IN009), NeoLumax® CLIA Analyzer (Ref IN010) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bath, Incubators/Water, All | JTQ | 1 | Manufacturer | accessdata.fda.gov |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Potassium | CEM | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion Specific, Sodium | JGS | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Ion-Specific, Chloride | CGZ | 2 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 27, 2018 | K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | JGS | Substantially Equivalent | Awareness Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bath, Incubators/Water, All
- All makers of Colorimeter, Photometer, Spectrophotometer For Clinical Use
- All makers of Electrode, Ion Specific, Sodium
- All makers of Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- All makers of Electrode, Ion-Specific, Chloride
- All makers of Electrode, Ion Specific, Potassium
Updated February 27, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.