BLOOD CULTURE HOLDER— 510(k) K122687

Substantially Equivalent

Greiner Bio-One North America, Inc.

FDA 510(k) clearance K122687 for BLOOD CULTURE HOLDER, Substantially Equivalent on 2013-01-10. Applicant: Greiner Bio-One North America, Inc..

Clearance details

Applicant: Greiner Bio-One North America, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2012-09-04
Decision date: 2013-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.