DADE RECOMBOPLASTIN S— 510(k) K921326

Name: FDA 510(k) clearance K921326
Creator: U.S. Food and Drug Administration
Published: 1992-07-27

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K921326 for DADE RECOMBOPLASTIN S, Substantially Equivalent on 1992-07-27. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code GJS
Device class: Class 2
Regulation: 21 CFR 864.7750
Advisory panel: Hematology
Date received: 1992-03-18
Decision date: 1992-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.