BIOTRACK APTT REAGENT CARTRIDGE— 510(k) K890052

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K890052 for BIOTRACK APTT REAGENT CARTRIDGE, Substantially Equivalent on 1989-02-24. Applicant: Biotrack, Inc.. Device class: 2.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1989-01-06
Decision date: 1989-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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