COAGULATION CONTROL, LEVEL III— 510(k) K870687

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K870687 for COAGULATION CONTROL, LEVEL III, Substantially Equivalent on 1987-04-20. Applicant: U. S. Diagnostics, Inc..

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1987-02-19
Decision date: 1987-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, 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.