BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST— 510(k) K860721

Name: FDA 510(k) clearance K860721
Creator: U.S. Food and Drug Administration
Published: 1986-05-23

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K860721 for BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST, Substantially Equivalent on 1986-05-23. Applicant: Biotrack, Inc.. Device class: 2.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1986-02-26
Decision date: 1986-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GJS

product code GJS

Death: 4
Injury: 229
Malfunction: 4,852
Total: 5,085

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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