BIOTRACK APTT CONTROLS— 510(k) K890051

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K890051 for BIOTRACK APTT CONTROLS, Substantially Equivalent on 1989-02-23. Applicant: Biotrack, Inc.. Device class: 2.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code GIT
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-01-06
Decision date: 1989-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE1992-07-23
K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE1992-07-23

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