Awareness Technology, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 18
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | February 27, 2018 |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | July 19, 2002 |
| K010877 | CHEMWELL, MODEL 2900 | May 23, 2001 |
| K974762 | STAT TRACKS | January 28, 1998 |
| K943729 | DYE CHECK STRIPS 545-630 | December 29, 1994 |
| K941394 | STAT FAX 2600 | June 3, 1994 |
| K923598 | REDI-CHECK PHOTMETER Q.A. | October 14, 1992 |
| K900224 | STAT FAX(TM)-2100 | March 1, 1990 |
| K892656 | DRI-DYE CHECK STRIPS (TM)-405 | May 22, 1989 |
| K882938 | STAT FAX(TM) | September 9, 1988 |
| K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB | November 4, 1987 |
| K871679 | FOCUS-GHB | July 28, 1987 |
| K864634 | AP1 COLORIMETER | December 31, 1986 |
| K861697 | SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT) | August 19, 1986 |
| K851467 | HEMOGLOBIN ANALYZER | July 16, 1985 |
| K850995 | SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P | May 10, 1985 |
| K850994 | SPECTRA 1 FILTER PHOTOMETER | May 10, 1985 |
| K850993 | SMART ALEX II MULTI-FILTER PHOTOMETER | May 7, 1985 |