Company ยท US
Awareness Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2018. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 8 |
| LCP | Assay, Glycosylated Hemoglobin | 2 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| JFS | Coulometric, Chloride | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2018 | K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) Awareness Technology, Inc. | JGS |
| Jul 19, 2002 | K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 Awareness Technology, Inc. | JLW |
| May 23, 2001 | K010877 | CHEMWELL, MODEL 2900 Awareness Technology, Inc. | CIX |
| Jan 28, 1998 | K974762 | STAT TRACKS Awareness Technology, Inc. | JJQ |
| Dec 29, 1994 | K943729 | DYE CHECK STRIPS 545-630 Awareness Technology, Inc. | JJY |
| Jun 3, 1994 | K941394 | STAT FAX 2600 Awareness Technology, Inc. | JQW |
| Oct 14, 1992 | K923598 | REDI-CHECK PHOTMETER Q.A. Awareness Technology, Inc. | JFS |
| Mar 1, 1990 | K900224 | STAT FAX(TM)-2100 Awareness Technology, Inc. | JJQ |
| May 22, 1989 | K892656 | DRI-DYE CHECK STRIPS (TM)-405 Awareness Technology, Inc. | JJX |
| Sep 9, 1988 | K882938 | STAT FAX(TM) Awareness Technology, Inc. | JJQ |
| Nov 4, 1987 | K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB Awareness Technology, Inc. | JJQ |
| Jul 28, 1987 | K871679 | FOCUS-GHB Awareness Technology, Inc. | LCP |
| Dec 31, 1986 | K864634 | AP1 COLORIMETER Awareness Technology, Inc. | JJQ |
| Aug 19, 1986 | K861697 | SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) Awareness Technology, Inc. | LCP |
| Jul 16, 1985 | K851467 | HEMOGLOBIN ANALYZER Awareness Technology, Inc. | KHG |
| May 10, 1985 | K850995 | SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P Awareness Technology, Inc. | JJQ |
| May 10, 1985 | K850994 | SPECTRA 1 FILTER PHOTOMETER Awareness Technology, Inc. | JJQ |
| May 7, 1985 | K850993 | SMART ALEX II MULTI-FILTER PHOTOMETER Awareness Technology, Inc. | JJQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||