ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST— 510(k) K862669

Name: FDA 510(k) clearance K862669
Creator: U.S. Food and Drug Administration
Published: 1986-10-03

Substantially Equivalent

U. S. Diagnostics, Inc.

FDA 510(k) clearance K862669 for ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST, Substantially Equivalent on 1986-10-03. Applicant: U. S. Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: U. S. Diagnostics, Inc.
Product code: Code GFD
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1986-07-14
Decision date: 1986-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Luis Obispo, CA, US

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Adverse events under product code GFD

product code GFD

Injury: 544
Malfunction: 3,575
Other: 1
Total: 4,120

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.