Biotrack, Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biotrack, Inc. Hematology ✕
7 devices
Cleared
Oct 10, 1989
BIOTRACK HEMOGLOBIN TEST CARTRIDGE
Hematology
56d
Cleared
Oct 10, 1989
BIOTRACK PDS MONITOR
Hematology
56d
Cleared
Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
Hematology
49d
Cleared
Feb 23, 1989
BIOTRACK APTT CONTROLS
Hematology
48d
Cleared
May 23, 1986
BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)
Hematology
86d
Cleared
May 23, 1986
BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
Hematology
86d
Cleared
May 23, 1986
BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST
Hematology
86d