EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628— 510(k) K875062

Name: FDA 510(k) clearance K875062
Creator: U.S. Food and Drug Administration
Published: 1988-02-11

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K875062 for EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628, Substantially Equivalent on 1988-02-11. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1987-12-09
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, 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.