BIOTRACK HEMOGLOBIN TEST CARTRIDGE— 510(k) K895101

Name: FDA 510(k) clearance K895101
Creator: U.S. Food and Drug Administration
Published: 1989-10-10

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K895101 for BIOTRACK HEMOGLOBIN TEST CARTRIDGE, Substantially Equivalent on 1989-10-10. Applicant: Biotrack, Inc.. Device class: 2.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 1989-08-15
Decision date: 1989-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE1992-07-23

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