Medical Device Manufacturer · US , Mchenry , IL

Data Medical Associates, Inc. - FDA 510(k) Cleared Devices

111 submissions · 111 cleared · Since 1978

111

Total

111

Cleared

0

Denied

FDA 510(k) Regulatory Record - Data Medical Associates, Inc. Chemistry ✕

106 devices

1-12 of 106

Cleared Oct 08, 1999

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003

Chemistry · 22d

Cleared May 29, 1997

DMA TRIGLYCERIDES PROCEDURES

Chemistry · 63d

Cleared Jul 01, 1996

DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

Chemistry · 45d

Cleared Feb 29, 1996

SERUM BICARBONATE/CARBON DIOXIDE

Chemistry · 101d

Cleared Feb 29, 1996

IRON CALIBRATOR & CALIBRATION VERIFICATION SET

Chemistry · 69d

Cleared Dec 20, 1995

TOTAL BILIRUBIN PROCEDURE

Chemistry · 30d

Cleared Oct 03, 1995

DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

Chemistry · 131d

Cleared Aug 23, 1995

DMA TOTAL CHOLESTEROL PROCEDURE

Chemistry · 247d

Cleared May 08, 1995

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE

Chemistry · 129d

Cleared Mar 01, 1995

DMA ALBUMIN PROCEDURE

Chemistry · 61d

Cleared Dec 06, 1994

DMA CALCIUM PLUS PROCEDURE

Chemistry · 96d

Cleared Oct 20, 1994

DMA GLUCOSE (OXIDASE) PROCEDURE

Chemistry · 106d

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