BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)— 510(k) K860719

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K860719 for BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST), Substantially Equivalent on 1986-05-23. Applicant: Biotrack, Inc..

Clearance details

Applicant: Biotrack, Inc.
Product code: Code JPA
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 ↗

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

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.