Medical Device Manufacturer · US , Palm City , FL

Awareness Technology, Inc. - FDA 510(k) Cleared Devices

18 submissions · 18 cleared · Since 1985

18

Total

18

Cleared

0

Denied

FDA 510(k) Regulatory Record - Awareness Technology, Inc. Chemistry ✕

15 devices

1-15 of 15

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

Chemistry · 40d

Cleared Dec 29, 1994

DYE CHECK STRIPS 545-630

Chemistry · 149d

Cleared Jun 03, 1994

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

Chemistry · 58d

Cleared Nov 04, 1987

PROJECT 300 MICROASSAY BP-12, EIA MINILAB

Chemistry · 69d

Cleared Dec 31, 1986

AP1 COLORIMETER

Chemistry · 36d

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