BIOTRACK CARBAMAZEPINE TEST CARTRIDGE— 510(k) K915756

Name: FDA 510(k) clearance K915756
Creator: U.S. Food and Drug Administration
Published: 1992-07-23

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K915756 for BIOTRACK CARBAMAZEPINE TEST CARTRIDGE, Substantially Equivalent on 1992-07-23. Applicant: Biotrack, Inc.. Device class: 2.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1991-12-23
Decision date: 1992-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLT

view all

K151578 — Carbamazepine Gen 42015-10-22
K123518 — ABBOTT CARBAMAZEPINE ASSAY2013-06-05
K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS2011-10-14
K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS2007-10-05
K042808 — ADVIA IMS CARBAMAZEPINE METHOD2005-02-08

More clearances from Biotrack, Inc.

view all

K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE1993-12-29
K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS1993-12-29
K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL1992-08-05
K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE1992-07-23
K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS1990-09-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.