Awareness Technology, Inc.
Palm City, FL, US
AWARENESS TECHNOLOGY, INC. appears in FDA device records in Palm City, FL. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Awareness Technology, Inc. between 1985 and 2018. The busiest year on record is 1985, with 4. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 4 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | JGS | Substantially Equivalent | |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | JLW | Substantially Equivalent | |
| K010877 | CHEMWELL, MODEL 2900 | CIX | Substantially Equivalent | |
| K974762 | STAT TRACKS | JJQ | Substantially Equivalent | |
| K943729 | DYE CHECK STRIPS 545-630 | JJY | Substantially Equivalent | |
| K941394 | STAT FAX 2600 | JQW | Substantially Equivalent | |
| K923598 | REDI-CHECK PHOTMETER Q.A. | JFS | Substantially Equivalent | |
| K900224 | STAT FAX(TM)-2100 | JJQ | Substantially Equivalent | |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | JJX | Substantially Equivalent | |
| K882938 | STAT FAX(TM) | JJQ | Substantially Equivalent | |
| K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB | JJQ | Substantially Equivalent | |
| K871679 | FOCUS-GHB | LCP | Substantially Equivalent | |
| K864634 | AP1 COLORIMETER | JJQ | Substantially Equivalent | |
| K861697 | SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) | LCP | Substantially Equivalent | |
| K851467 | HEMOGLOBIN ANALYZER | KHG | Substantially Equivalent | |
| K850995 | SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P | JJQ | Substantially Equivalent | |
| K850994 | SPECTRA 1 FILTER PHOTOMETER | JJQ | Substantially Equivalent | |
| K850993 | SMART ALEX II MULTI-FILTER PHOTOMETER | JJQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1036223 | 1036223 | AWARENESS TECHNOLOGY, INC. | 1935 S.W. MARTIN HWY., PALM CITY, FL 34990 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- JTQBath, Incubators/Water, All
- CIXBromcresol Green Dye-Binding, Albumin
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JFSCoulometric, Chloride
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JQWStation, Pipetting And Diluting, For Clinical Use
- KHGWhole Blood Hemoglobin Determination
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain