Medical Device Manufacturer · US , Bedford , MA

Esa, Inc. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 1987

7

Total

7

Cleared

0

Denied

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

5 devices

1-5 of 5

Cleared Jan 30, 2004

ESA PLASMA FREE METANEPHRINE ANALYSIS KIT

Chemistry · 196d

Cleared Dec 26, 1996

MODEL 5500 CEAS

Chemistry · 86d

Cleared Jan 11, 1994

MODEL 5500 CEAS

Chemistry · 84d

Cleared Jun 09, 1993

MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM

Chemistry · 96d

Cleared Apr 13, 1987

NEUROCHEMICAL ANALYZER

Chemistry · 130d