Biotrack, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biotrack, Inc. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Biotrack, Inc. has 16 FDA 510(k) cleared medical devices. Based in Sunnyvale, US.
Historical record: 16 cleared submissions from 1986 to 1993. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Biotrack, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biotrack, Inc.
16 devices
Cleared
Dec 29, 1993
BIOTRACK VALPROIC ACID TEST CARTRIDGE
Toxicology
132d
Cleared
Dec 29, 1993
BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS
Toxicology
132d
Cleared
Aug 05, 1992
BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL
Toxicology
183d
Cleared
Jul 23, 1992
BIOTRACK PHENYTOIN TEST CARTRIDGE
Toxicology
213d
Cleared
Jul 23, 1992
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE
Toxicology
213d
Cleared
Sep 17, 1990
BIOTRACK THEOPHYLLINE QUALITY CONTROLS
Toxicology
24d
Cleared
May 30, 1990
BIOTRACK THEOPHYLLINE TEST CARTRIDGE
Toxicology
124d
Cleared
Feb 23, 1990
BIOTRACK IMMUNOCHEMISTRY MONITOR
Toxicology
28d
Cleared
Oct 10, 1989
BIOTRACK HEMOGLOBIN TEST CARTRIDGE
Hematology
56d
Cleared
Oct 10, 1989
BIOTRACK PDS MONITOR
Hematology
56d
Cleared
Oct 06, 1989
BIOTRACK ALT TEST CARTRIDGE
Chemistry
50d
Cleared
Feb 24, 1989
BIOTRACK APTT REAGENT CARTRIDGE
Hematology
49d