Medical Device Manufacturer · US , Sunnyvale , CA

Biotrack, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1986

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biotrack, Inc. Toxicology ✕

8 devices

1-8 of 8

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