CLP PROTHROMBIN TIME TEST— 510(k) K880566

Name: FDA 510(k) clearance K880566
Creator: U.S. Food and Drug Administration
Published: 1988-03-23

Substantially Equivalent

Creative Laboratory Products, Inc.

FDA 510(k) clearance K880566 for CLP PROTHROMBIN TIME TEST, Substantially Equivalent on 1988-03-23. Applicant: Creative Laboratory Products, Inc.. Device class: 2.

Clearance details

Applicant: Creative Laboratory Products, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1988-02-10
Decision date: 1988-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.