Kurin Blood Culture Collection Set— 510(k) K162233

Substantially Equivalent

Pathway, LLC

FDA 510(k) clearance K162233 for Kurin Blood Culture Collection Set, Substantially Equivalent on 2016-12-23. Applicant: Pathway, LLC.

Clearance details

Applicant: Pathway, LLC
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 2016-08-08
Decision date: 2016-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, CA, 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.