Awareness Technology, Inc. is one of 18088 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Awareness Technology, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-), CHEMWELL, ALSO KNOWN AS PROJECT 2900, CHEMWELL, MODEL 2900
18
Total
18
Cleared
0
Denied
Awareness Technology, Inc. has 18 FDA 510(k) cleared chemistry devices. Based in Palm City, US.
Historical record: 18 cleared submissions from 1985 to 2018.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Awareness Technology, Inc.
18 devices
Cleared
Feb 27, 2018
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)
Chemistry
284d
Cleared
Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
Chemistry
277d
Cleared
May 23, 2001
CHEMWELL, MODEL 2900
Chemistry
61d
Cleared
Jan 28, 1998
STAT TRACKS
Chemistry
40d
Cleared
Dec 29, 1994
DYE CHECK STRIPS 545-630
Chemistry
149d
Cleared
Jun 03, 1994
STAT FAX 2600
Chemistry
73d
Cleared
Oct 14, 1992
REDI-CHECK PHOTMETER Q.A.
Chemistry
86d
Cleared
Mar 01, 1990
STAT FAX(TM)-2100
Chemistry
43d
Cleared
May 22, 1989
DRI-DYE CHECK STRIPS (TM)-405
Chemistry
39d
Cleared
Sep 09, 1988
STAT FAX(TM)
Chemistry
58d
Cleared
Nov 04, 1987
PROJECT 300 MICROASSAY BP-12, EIA MINILAB
Chemistry
69d
Cleared
Jul 28, 1987
FOCUS-GHB
Hematology
90d
Cleared
Dec 31, 1986
AP1 COLORIMETER
Chemistry
36d
Cleared
Aug 19, 1986
SELF ASSURE/GHB (CAPILLARY-BLOOD COLLECTION KIT)
Hematology
106d
Cleared
Jul 16, 1985
HEMOGLOBIN ANALYZER
Hematology
92d
Cleared
May 10, 1985
SPECTRA 1 FILTER PHOTOMETER
Chemistry
60d
Cleared
May 10, 1985
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
Chemistry
60d
Cleared
May 07, 1985
SMART ALEX II MULTI-FILTER PHOTOMETER
Chemistry
57d