OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376— 510(k) K926222

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K926222 for OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376, Substantially Equivalent on 1993-02-12. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code JPA
Advisory panel: Hematology
Date received: 1992-12-10
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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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.