Analytical Control Systems, Inc. - FDA 510(k) Cleared Devices
42
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Analytical Control Systems, Inc. Hematology ✕
18 devices
Cleared
Mar 07, 1997
SPECKTIN-LA TEST SET
Hematology
295d
Cleared
Apr 27, 1993
ACS APCT REAGENT, MODIFIED
Hematology
158d
Cleared
Mar 23, 1993
COAGULATION CONTROL CONTAINING HEMOGLOBIN
Hematology
154d
Cleared
Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
Hematology
158d
Cleared
Jul 28, 1992
ACS APCT REAGENT
Hematology
141d
Cleared
Dec 04, 1991
ACS ULTRA-1 THROMBOPLASTIN
Hematology
135d
Cleared
Nov 27, 1991
ACS ULTRA-2 THROMBOPLASTIN
Hematology
128d
Cleared
Aug 09, 1991
ACS LIQUID THROMBOPLASTIN
Hematology
88d
Cleared
Aug 10, 1990
ACS ONE-STAGE PROTHROMBIN TIME REAGENT
Hematology
67d
Cleared
Aug 06, 1990
ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
Hematology
59d
Cleared
Jul 24, 1990
ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)
Hematology
50d
Cleared
Jul 24, 1990
ABNORMAL GLYCOHEMOGLOBIN CONTROL
Hematology
50d
Cleared
Aug 03, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
Hematology
17d
Cleared
Jul 25, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
Hematology
53d
Cleared
Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
Hematology
53d
Cleared
Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
Hematology
11d
Cleared
Jun 23, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL I
Hematology
32d
Cleared
Jun 23, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL I
Hematology
32d