THROMBOREL S— 510(k) K872844

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K872844 for THROMBOREL S, Substantially Equivalent on 1987-08-06. Applicant: Behring Diagnostics, Inc..

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GJS
Advisory panel: Hematology
Date received: 1987-07-20
Decision date: 1987-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

Download summary PDF View on FDA.gov ↗

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.