Medical Device Manufacturer · US , Mchenry , IL

Analytical Control Systems, Inc. - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1979

Recent clearances: SPECKTIN-LA TEST SET, ACS CARDIO-TROL CONTROL, ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL

42

Total

42

Cleared

0

Denied

FDA 510(k) Regulatory Record - Analytical Control Systems, Inc. Chemistry ✕

15 devices

1-15 of 15

Cleared Jul 20, 1994

ACS CARDIO-TROL CONTROL

Chemistry · 135d

Cleared Apr 20, 1994

ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL

Chemistry · 98d

Cleared Mar 11, 1994

ACS O DILVENT PROTEIN DILUTION MATRIX

Chemistry · 43d

Cleared Jun 07, 1993

ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR

Chemistry · 129d

Cleared Feb 18, 1993

NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL

Chemistry · 90d

Cleared May 01, 1991

ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1

Chemistry · 56d

Cleared Dec 26, 1990

ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR

Chemistry · 65d

Cleared Dec 07, 1990

HDL CHOLESTEROL CONTROL

Chemistry · 38d

Cleared Dec 06, 1990

ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL

Chemistry · 42d

Cleared Aug 01, 1990

ACS 0.02 M CALCIUM CHLORIDE

Chemistry · 58d

Cleared Jun 21, 1989

ACS COLLOID OSMOTIC PRESSURE CALIBRATOR

Chemistry · 79d

Cleared Mar 25, 1980

LIPID CONTROL PRODUCT # ACS LC 101

Chemistry · 13d

Cleared Mar 25, 1980

SERTROL PRODUCT # ACS ST 101

Chemistry · 13d

Cleared Mar 12, 1980

CK/LD ISOENZYME CONTROL PROD. #ACS CT101

Chemistry · 21d

Cleared Oct 01, 1979

LY-PRO-TROL #ACS-LP101

Chemistry · 14d