FDA Registration
Active
🇺🇸 United States
AWARENESS TECHNOLOGY, INC.
Reg #: 1036223
·
FEI: 1036223
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
2
Classifications
7
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Registration Details
- Registration Name
- AWARENESS TECHNOLOGY, INC.
- Registration Number
- 1036223
- FEI Number
- 1036223
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1935 S.W. MARTIN HWY.
- City
- PALM CITY
- State
- FL
- ZIP
- 34990
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171476
Owner / Operator
- Firm Name
- AWARENESS TECHNOLOGY, INC.
- Operator Number
- 1036223
- Address
- 1935 S.W. MARTIN HWY., --
- City
- Palm City
- State
- FL
- Postal Code
- 34990
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 1992-07-07 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 1992-07-07 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 1994-04-22 |
| Electrode, Ion Specific, Sodium | JGS | Class 2 | Clinical Chemistry | No | 2018-08-15 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2018-08-15 |
| Electrode, Ion-Specific, Chloride | CGZ | Class 2 | Clinical Chemistry | No | 2018-08-15 |
| Electrode, Ion Specific, Potassium | CEM | Class 2 | Clinical Chemistry | No | 2018-08-15 |
Proprietary Names
STAT FAX 2200
CHEMWELL
STAT WASH
SELECTALYTE
PrisMatic® ELISA Analyzer (Ref IN013)
Autoplex® ELISA & CLIA Analyzer (Ref IN006)
NeoEldex® ELISA Analyzer (Ref IN009)
Autoplex® 3rd Generation Dual Plate ELISA Analyzer (Ref IN006-3)
Immunoassay Plate Washer (Ref IN002)
NeoLumax® CLIA Analyzer (Ref IN010)
LuMatic® CLIA Analyzer (Ref IN008)
Autoplex® 2nd Generation ELISA & CLIA Analyzer (Ref IN006-2)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)