BIOTRACK PDS MONITOR— 510(k) K895102

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K895102 for BIOTRACK PDS MONITOR, Substantially Equivalent on 1989-10-10. Applicant: Biotrack, Inc.. Device class: 1.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
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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More clearances from Biotrack, Inc.

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K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE1992-07-23

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