Awareness Technology, Inc.
Medical device manufacturer in Palm City, FL.
18510(k) clearances
0PMA approvals
0recalls
Device types
- JJQ Colorimeter, Photometer, Spectrophotometer… 8
- LCP Assay, Glycosylated Hemoglobin 2
- KHG Whole Blood Hemoglobin Determination 1
- JJX Single (Specified) Analyte Controls… 1
- JFS Coulometric, Chloride 1
- JQW Station, Pipetting And Diluting, For… 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 1
- JGS Electrode, Ion Specific, Sodium 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | 02/27/2018SE |
| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | 07/19/2002SE |
| K010877 | Chemwell, Model 2900CIX · Abbreviated | 05/23/2001SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | 10/14/1992SE |
| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
| K873451 | Project 300 Microassay BP-12, Eia MinilabJJQ · Traditional | 11/04/1987SE |
| K871679 | Focus-GhbLCP · Traditional | 07/28/1987SE |
| K864634 | AP1 ColorimeterJJQ · Traditional | 12/31/1986SE |
| K861697 | Self Assure/Ghb (Capillary-Blood Collection Kit)LCP · Traditional | 08/19/1986SE |
| K851467 | Hemoglobin AnalyzerKHG · Traditional | 07/16/1985SE |
| K850995 | Smart Alex Compact Clinical Analyzer(Cca)(Filter PJJQ · Traditional | 05/10/1985SE |
| K850994 | Spectra 1 Filter PhotometerJJQ · Traditional | 05/10/1985SE |
| K850993 | Smart Alex II Multi-Filter PhotometerJJQ · Traditional | 05/07/1985SE |